chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient was administered COVID-19 Bivalent vaccine on date 10/04/22. Patient has not have previous covid-19 Pfizer vaccines. Bivalent was administered as primary series. No adverse reactions were reported on 15 minute wait in room after administration of vaccine or until today.  The CDC department and infection specialist have been contacted by patients' PCP. According  to CDC and infection specialist there is no reason to worry. Patient will come within three weeks to receive booster. Parents have been notified as well.
This spontaneous report was received from a pharmacist referring to unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On an unknown date the patients were vaccinated with improperly stored doses of ZOSTAVAX 19400 PFU, which had lot # L046896, expiry date: 28-FEB-2017 (dose and route not reported). No adverse effects reported. No further information provided. Additional information has been requested.
Injection site was erythematous, edematous, tender to touch and warm to touch.
Fever (100.5 persisting ~12 hours) Chills/sweats Aches  Fatigue
Breakthrough COVID test: I started to experience sniffles. The following day, 01/06/2022, I had congestion and drainage. I went to bed and the next 3 days I had congestion and night chills. I was extremely fatigue. 01/08/2022 I did a rapid test at a pharmacy and it came back positive. On 01/12/2022 I went to a drive through COVID testing site to have a PCR test which came back positive again. On 01/17/2022 I contacted my doctor and I was prescribed an albuterol inhaler and azithromycin. I never experienced a fever and my O2 levels were 93-95%. On 01/21/2022 I went to a clinic and tested negative.
On the evening of 3/05 I experienced a sore arm and a slight temperature (98.8--about 1+degree from my normal).  The next morning I began a bike ride and within a few blocks was having sore arms and extreme fatigue.  I went home, took my BP and it was 101/59.  On 3/07 I used a stationary bike at the gym, came home very fatigued and BP was 92/63.  On 3/08 it was 111/61 after I spent 2 hrs or so flying airplanes, my other hobby.  Today I tried a bike ride again, quickly got shoulder, arm and back pain and extreme fatigue--came home and BP was 90/59.  I ate lunch, drank a Coke for caffeine, tried to ride again and it was 104/61 after a short ride.
she had a stroke; Cardiac Allograft Vasculopathy; Cardiac Allograft Vasculopathy; Hand tremors; lack of coordination; could not grab things; numbness in the hands and head; This is a spontaneous report from contactable pharmacist via Pfizer sales representative. A 71-year-old female patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), via an unspecified route of administration on an unspecified date in May2019 at single dose for immunization.  Medical history included open heart surgery and CV (Cardiovascular) history.  The patient's concomitant medications were not reported.  The patient experienced hand tremors, lack of coordination, could not grab things, numbness in the hands and head, she also mentioned that she had a stroke (CVA (Cardiac Allograft Vasculopathy)) after four weeks of the administration of pneumococcal 13-val conj vac (dipht crm197 protein), all in 2019 and with outcome of unknown.; Sender's Comments: Stroke manifested as tremors,  lack of coordination,  could not grab things,  numbness in the hands and head represents an coincidental occurrence; Cardiac allograft vasculopathy is attributable to the underlying cardiac conditions, both of which are not related to the vaccination with PREVNAR 13.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Patient felt nauseous and a bit warm  during the first 15 minutes of waiting after receiving her first shot of Moderna Covid 19 vaccine. I monitored her and decided to get  her a bag in case she had to throw up. She threw up suddenly.  She said she was feeling much better and the warmth and nausea was a level 2 (On a scale of 1 to 10 with 10 being the most severe). I informed her that I will have to monitor her for an additional 15 minutes because of her event. She waited a total of about 40 minutes after her injection. She said she felt fine and left. I called her later during the day. She said she was still okay without any problems. I informed her to seek the counsel of her doctor for the doctor to decide on whether or not she should get her second Covid shot.
Patient passed 42 days without second dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Patient passed 42 days without second dose) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jul-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Patient passed 42 days without second dose). On 16-Jul-2021, PRODUCT DOSE OMISSION ISSUE (Patient passed 42 days without second dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided. Treatment information was not provided.
localized erythema, warmth, pain approx 7cm x 8cm @ inj site lt deltoid;
facial swelling; angioedema; This spontaneous case was reported by an other health care professional and describes the occurrence of SWELLING FACE (facial swelling) and ANGIOEDEMA (angioedema) in a 25-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030H21B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 18-Jan-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2022, the patient experienced SWELLING FACE (facial swelling) (seriousness criteria medically significant and life threatening) and ANGIOEDEMA (angioedema) (seriousness criteria medically significant and life threatening). At the time of the report, SWELLING FACE (facial swelling) and ANGIOEDEMA (angioedema) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment medication was reported.  Company comment- This spontaneous case concerns a 25-year-old male patient with no reported medical history, who experienced unexpected, serious (life-threatening, medically significant) event of Swelling face and Angioedema 8 days after vaccination with a first dose of mRNA-1273. No further information was provided. The outcome of the events was reported as resolved. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   Reporter did not allow further contact; Sender's Comments: This spontaneous case concerns a 25-year-old male patient with no reported medical history, who experienced unexpected, serious (life-threatening, medically significant) event of Swelling face and Angioedema 8 days after vaccination with a first dose of mRNA-1273. No further information was provided. The outcome of the events was reported as resolved. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Information has been received from a nurse concerning a 7 year old white female with no known drug allergies who on 12/5/1997 was vaccinated SC in the right thigh with a first dose of varicella virus vaccine live (lot 624249/1103E). On approximately 3/30/2005, now she has experienced full blown chicken pox with lesions on her neck, scalp, head, legs and trunk. She is being treated with acyclovir (Zovirax). No product quality complaint was involved. Follow up information indicated that the patient had varicella illness on 3/27/2005. No labs or diagnostic test were done. The patient recovered. The patients experienced was considered an other important medical event (OMIC). Additional information is not expected.
From the patient  I participated in phase 3 randomized, Double-Blind, placebo controlled Center study for Clinical Research back in December of 2020 to determine the safety and efficacy of AstraZenecas, a combination of 2 of their monoclonal antibodies (AZD8895 and AZD1061) to preexposure prophylaxis in COVID-19 I was told to wait at 90 days before I got my vaccine and I think I should have waited much longer.  Not long after I received the monoclonal antibody treatment I started to have really bad depression issues and anger problems that seemed to last up to around mid April of 2021. I also had my hepatitis viral load go from 180,000 to 580,000 in just a few months so a massive jump in hep c viral load. I reported all of this to them and they assured me that I was fine and the promised I?d be ok.  I recently got the Pfizer vaccine with my second dose being on May the 7th 2021. My first dose on April the 16th was felt within minutes and I thought I was going to have to ask a staff worker with help getting out to the car.  I was very sick for a day or so and it made me very frightened to get the second one. So much that I contacted The  council about it. Everyone was extremely polite and very helpful.  I got my second dose and it was not as bad to go through but now I have a constant fungal infection that I can not get rid of and if I eat sweets it gets really bad.  My concern is not for anyone getting just the vaccine but for the people who have had the monoclonal antibodies and then getting the vaccine within 3 months.  The second dose seemed to make me angry but it did not last as long.  I?m worried about the effects other people may have had by combining the 2 or maybe not waiting longer before getting the actual vaccine. I don?t know but I can?t get rid of this fungus and I?m not sure else who to report it to. I?ve obviously shown it to my doctor. He gave me anti fungal creams but it turns out I have an allergy to fungal creams.  I did let the drug trial site know what happened as well.  I do not think it?s a Pfizer thing but a combination of it with the AstraZeneca monoclonal antibodies and the vaccine.
Localized redness, pain, swelling and warmth within 24 hours.  Also low grade temperature and myalgia.  No regenerating symptoms or generalized urticaria.  Area of erythema increased and Keflex 250 qid for 7 days given to cover cellulitis (right arm).
On 5/8/00, the pt received her first injection with Lymerix. On 5/16/00, eight days later, she experienced itching and a rash over her entire body. Apparently, this resolved spontaneously. On 5/24/00, the rash and itching began again and she also had "oozing skin blotches" all over her body. The pt reported she was sent home from work. She complained of muscle and joint pain, sore throat, runny nose, flu-like symptoms, upper body, facial, and jaw pain, headache, "ice cold feet", and elevated blood pressure (152/90). She saw an MD and was prescribed prednisone, Benadryl, hydroxyzine, and lorazapam. A complete blood count and blood chemistry was performed. He symptoms reportedly worsened, and prednisone was increased. On 6/1/00, she discontinued lorazapam and hydroxyzine and afterward "felt sick". Reportedly, all medications were eventually discontinued, and the rash resolved. However, the itching persisted. On 6/9/00, the rash returned. The pt reported she returned to work on 6/12/00 but was again sent home. This case is considered ICH serious as the events were reportedly incapacitating. Additional information has been requested.
[Patient was seen at hospital ER on 11-29-11] Patient got up in the AM and was tired. Felt ill and went to the trash can due to nausea and passed out. Was passed out for three/four minutes, woke & vomited. 911 rescue came and ambulance transported to hospital.
DEATH; BLOOD CLOT; This spontaneous report received from a consumer via through a company representative concerned a female of unspecified age, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose number in series 1, 1 total, dose and start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced blood clot and she could not have her needed daily dialysis. On an unspecified date, the patient died from unknown cause of death (dose number in series 1). It was unspecified whether an autopsy was performed. The consumer reported as "My sister in law died in a few days because her pokes caused her blood to clot, and she could not have her needed daily dialysis". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died from unknown cause of death on an unspecified date, and the outcome of blood clot was not reported. This report was serious (Death, and Other Medically Important Condition). This case, from the same reporter is linked to 20220126450, 20220126211, 20220126582, 20220126614, 20220126701 and 20220126708.; Sender's Comments: V0: 20220126177 -Covid-19 vaccine ad26.cov2.s- Death, Blood clot. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Burning sensation at time of injection, 1.5 inch diameter of mild erythematous patch, slightly elevated, tingling.
Began with sore throat in 24 hours.  Rapidly turned into a terrible Cold with two degrees fever,  Horrible runny nose and aching joints in every joint in my body.  Coughing, listless with no energy, no appetite and sleeping constantly.  Head congestion has made it almost impossible to sleep at night in bed and am urinating every hour with great urgency to do so.
Covid arm, red lesion, hard, painful, a little itchy, has been there for a week, gotten worse over time
Immediately after the vaccine was administered I experienced the usual side effects of mild headache, fatigue and localized redness and swelling  Around 11pm the night the vaccine was administered I developed a migraine that resulted in blurred vision. and when I checked my temperature it was approximately 104.9 degrees Fahrenheit.By the next morning, approximately 7am, I was weak to the point I could not get out of bed myself, I was nauseous that resulted in a single Emesis episode approximately 8am, I had mild swelling of my face since 7am, between 7:30am and 12pm, I had multiple times where I would temporarily lose my vision. Throughout 1/25 I continued to have a fever ranging from 102 degrees Fahrenheit to 103 degrees Fahrenheit. At approximately 8am and 1pm I took two acetaminophen pills each time which alleviated the migraine and to an extent helped with the visual deficit episodes. Throughout 1/24 and 1/25 I suffered with extreme chills resulting in shivering that lasted for several minutes despite a room temperature of approximately 90 degrees Fahrenheit and covered in two blankets. PCP was consulted via telephone and she advised to go to the hospital via EMS given the high grade fever, abnormal vitals and severity of symptoms
Red, angry ,hard, painful area  (2-3 inches)around injection site..persisting for 1 week Unusual lethargy mild+ for 1 week
The day of the injection my arm was mildly tender for a couple days but I did have a quarter-sized dark bruise at the injection site and it had bled.  About a week later the bruise started to lighten and the arm around the bruise became reddened, swollen and tender.  Each day the bruise got lighter and the other symptoms were reduced.  It was almost like some of the vaccine was in the bruise area and as it was released it affected the arm.  It is improving on its own with no other side effects.
Pt recvd vax 21JAN94; PE WNL; vomiting began 24JAN93 w/some min. behavioral change, loss of appetite; arrived in ER early 25JAN94 in full cardiac arrest resusitation attempts failed;
Injection given 7/20/09 right deltoid; Pt states "later that eve" site with redness edema pn.  Sxs cont'd and increased.  Pt presented to clinic 7-23-08 for assessment.  Cool compresses and Rx for HYDROXYEINE recommended.
Some Anosmia and profound Parosmia, joint pain, and muscle pain/weakness  my GP recommended Vit D and B-complex for the joint/muscle issues (with some success)  Regularly inhaling essential oils of Lemon, Clove, Rose, and Eucalyptus for 15 seconds each (almost no success)
Pt woke up on 05/06/2021 with the left side of his face swollen and his forehead was swollen.
got dealy sick; Initial information received on 08-Oct-2020 regarding an unsolicited valid non-serious case received from a consumer or non-healthcare professional.   This case involves patient (unknown demographics) who experienced to got dealy sick (illness), when received vaccine INFLUENZA VACCINE.  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer, lot number not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a to got dealy sick (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  Laboratory details were not reported.  It was not reported if the patient received a corrective treatment.  The event outcome was unknown for illness.  There will be no information available on the batch number for this case.
She was hospitalized before recieving 2nd dose due to underlying health conditions.; It is already more than 42 days after the first shot / Her specialist advised her not to receive her second dose at this time; This spontaneous case was reported by a pharmacist and describes the occurrence of GENERAL PHYSICAL HEALTH DETERIORATION (She was hospitalized before recieving 2nd dose due to underlying health conditions.) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 07-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced GENERAL PHYSICAL HEALTH DETERIORATION (She was hospitalized before recieving 2nd dose due to underlying health conditions.) (seriousness criterion hospitalization) and PRODUCT DOSE OMISSION ISSUE (It is already more than 42 days after the first shot / Her specialist advised her not to receive her second dose at this time). At the time of the report, GENERAL PHYSICAL HEALTH DETERIORATION (She was hospitalized before recieving 2nd dose due to underlying health conditions.) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (It is already more than 42 days after the first shot / Her specialist advised her not to receive her second dose at this time) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter.  Treatment information was not provided.  Company Comment: Very limited information regarding this event/s has been provided at this time. However, more information is required for further assessment.   Most recent FOLLOW-UP information incorporated above includes: On 25-Jul-2021: Additional information received- case upgraded to serious, new event added.; Sender's Comments: Very limited information regarding this event/s has been provided at this time. However, more information is required for further assessment.
Developed swelling and redness to vaccine injection site on patient's left thigh (site where Var#1 and PCV#4 were given).
It started that same day, I had chills, cold sweats, diarrhea and dry heaving. It felt like I had to vomit but couldn't. I couldn't eat or drink anything because I felt so nausea. It lasted about 24 hours. I didn't see that doctor, I just stayed in the bed the entire time.
09/14/2012-Headache. 09/15/2012- Fever 101.3; absence seizure; confusion; subsequent fatigue.
Pt received vaccines @ 9am 1/3/02, onset of urticaria, fever 101-103F 6pm through 1/4/02. Symptoms resolved 1/5/02am. 2nd episode diffuse hives day of vaccines.
Patient started itching behind both ears and on both ear lobes 30 minutes after vaccination. She reported feeling warm all over. No difficulty breathing or hives or any other complaint. Patient was given Benadryl PO 50mg at 1515. patient reported no more itching 5 minutes later. She said she still felt warm when leaving. Husband took her home.
About 8 hours later, feelings of muscular pain, fever, extreme fatigue, malaise. Malaise, muscle pain and extreme fatigue Continued for 3 weeks until middle of March around March 20 subsided.
My hair started falling out drastically within a couple days of getting the first and second vaccine and it?s still falling out immensely. My period was also 10 days late and it?s never late
10/11/2004 2:00PM, Resident received Flu injection.  5:00PM resident was having some jerking, chills and fever.  Doctor notified.  Dr. said to monitor and give Tylenol 500 mg (2) for fever and comfort.  7:10PM temp. decreased to 103.2 - Family in.  8:00PM temp. 100.7 - patient rested all night.
14-24hours of muscle aches. 20-48 hours fatigue. All symptoms resolved within 48hours of vaccine
Acute disseminated encephalomyelitis (ADEM) is a neurological condition characterized by a brief but intense attack of inflammation in the brain and spinal cord. Patient developed altered mental status, confusion and seizures, currently intubated. MRI Brain consistent with severe diffuse  inflammation and vasogenic edema of cerebrum, bilateral cerebellum, brainstem and thalamus. NO hemorrhage no acute stroke, CSF did not show active Bacterial, viral or fungal infection. Getting Brain bx now.
Swelling at injection site for approx. 24 hours.  Sudden onset of wheezing for approx. 30 minutes.  Extreme tiredness next day.
4/7/21 - arm pain 4/8/21 - severe headache/migraine, dizziness, extreme fatigue, weakness, light sensitivity, nausea, burping, insatiable thirst despite being well hydrated, dry mouth, hot/cold fluctuations, low grade fever 99.1, congestion, loss of appetite, constipation despite eating foods that help, unusual internal sensation (not sure how to describe; perhaps flutter), heaviness in breathing, brain fog. 4/9/21 - varying durations and frequencies of vertigo, nausea, chronic fatigue, malaise, chronic thirst, headache, dizziness, heaviness in breathing, constipation, congestion, brain fog.  4/10/21 - varying durations and frequencies of fatigue, dizziness, chronic thirst, constipation, headache, heaviness in breathing, brain fog 4/11/21 - varying durations and frequencies of headache, malaise, dizziness, fatigue, thirst, brain fog
Pt began experiencing redness near injection site and pruritis; applied hydrocortisone to relieve itching; pt states that it is getting better.
Skin rash/hives over most of body. Fever (104-105) started 10 days post inj. Followed by rash body and hives (measle looking rash).