chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I received my second dose of Pfizer around 3pm on Sunday, April 4 2021. By about midnight, I had a fever and the fever/headache and exhaustion persisted throughout Monday. I did not take any medicine. By Tuesday morning, my fever broke, but I developed a large 6 inch rash under my left armpit (my second shot was in my right arm as I am left handed). By Tuesday afternoon, I had developed a bad cough. Given that I work remotely, and had only been to a grocery store (double masked) with my mother a few days prior to the second dose, I assumed the cough was a result of the second dose. My cough become worse, and by Wednesday it sounded like bronchitis so I went to my doctor. She believed that it was a bronchitis cough, had me tested for viral infections, and put me on a variety of medications from antibiotics to steroids and inhalers. I tested negative for all the respiratory illnesses I was tested for, as well as COVID-19. The medications did not seem to help, and my doctor added another inhaler and medication to the mix. After about 2 weeks of medications and no improvements, my doctor had me get a chest X-ray to make sure I didn?t have pneumonia or any other obstruction in my lungs. I also stopped all medication on Tuesday, April 20. My chest X-ray came back clear later that week, and I decided to just stay off all medications and hope that my body would self heal, since this seemed to be a self created bronchitis, as my parents did not get sick. Finally, after 2 weeks and 4 days, my cough has improved significantly to the point where I can now talk almost normally, without going into coughing spasms and feeling as though it was difficult to breathe.
COVID AFTER BEING VACCINATED WITH THE JANSSEN COVID 19 VACCINE; This spontaneous report received from a patient concerned a 39 year old male. 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 not reported, batch number: 211A21A, and expiry: 14-DEC-2021) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the patient experienced covid after being vaccinated with the janssen covid 19 vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of covid after being vaccinated with the janssen covid 19 vaccine was not reported. This report was non-serious. This report was associated with product quality complaint.
I had been going to the doctor for my back pain as I had caught my dad from falling and thought that I had tweaked my back. They had ordered an x-rays that looked fine, my back was not getting batter. I now had numbness that was going all the way down my side. My doctor ordered an MRI with and without contrast. The results came back showing that my breast cancer has come back, but it is metastatic cancer. The cancer is from  my brain to my toes. It is a ductual cancer.
mom states child exp weakness & tiredness of both lower limb joints approx 24hr p/vax;this episode lasted for 2 days;
Saturday (2/4/21) morning the patient noticed that her arm ( shoulder/deltoid area) was hot to touch, red and pain radiating from the area. Saturday around noon the Redness started to spread to 1 inch above the elbow. Saturday around 4pm the redness has spread past beyond the elbow. Inform patient to go to urgent care. At urgent care the patient received a steroid shot and a Rx for Keflex.  Sunday (2/5/21) morning  contacted patient  the symptoms of pain has decreased to a minimal level.  The shoulder/ deltoid area still had some redness but the redness started to subside around her elbow area.  Tuesday (2/09/21) The patient  came in to follow up in person. The patient is no longer experiencing any signs or symptoms of the adverse event. No redness upon visual inspection.
ErythemaMultiform swelling at site of injection Narrative:  employee experiencing swelling & redness in arm apx 10min post injection. vital signs stable at 133/82 HR 78 O2 97% T 98.4 RR16. no further symptoms after 30min monitoring. returned to clinic at 1430 with increased redness/swelling w/new onset of itching near injection site. VS: 138/83 HR 69 O2 96% T99 RR 16. Admin 50mg IV Benadryl. code team arrived and took to ED for further monitoring.
Patient is not experiencing an adverse event.  I realized four days after administering the vaccine that the  patient was not of recommended age to receive.
After vaccination employee left and returned to her department. There is no prior history of vaccine sensitivity. She began to feel dizzy then developed a dry mouth and hives on her neck and chest. She was seen in the ED where she received 0.3 mg epinephrine IM and 10 mg ZYRTEC by mouth. She improved after the meds and returned to her department in stable condition.
This initial, unsolicited case was received on 02 January 2015 from a registered nurse. A male pediatric patient, age not reported, received a DTaP vaccine (manufacturer and lot number not reported) on an unspecified date and subsequently experienced bloody stools "again". The patient had a history of extreme dairy allergy, and per the reporter the bloody stools were an indication of dairy intolerance/allergy. Outcome was not reported. Documents held by sender: None.
Drug ineffective; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Nov2022 at 12:00 as dose 4 (booster), single (Lot number: GS3275) at the age of 46 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Autoimmune disorders" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant) with onset Apr2023, outcome "unknown"; DRUG INEFFECTIVE (medically significant) with onset Apr2023, outcome "unknown". Therapeutic measures were taken as a result of Drug ineffective, Covid-19 which includes Paxlovid treatment from 17Apr2023 to 21Apr2023. Clinical course: It was unknown if the patient had other medication in 2 weeks. The patient had no known allergies. Took and completed 5 days of Paxlovid on day 3 of Covid 19 symptoms.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300175652 same patient/reporter, different drug/event;
Systemic: patient developed shingles 6 days later-Severe, Additional Details: patient diagnosed with shingles 6 days later. unkown if 100% related to vaccine but completing VAERs regardless
Patient arrived into  vaccine cloinic accompanied by ex boyfriend. Patient made staff aware that she was previously hospitalized for flu vaccine in the past. Patient verbalized "pre-medicating" with Allegra PO prior to arriving at the vaccination clinic. Therefore, patient was brought to stretcher in our obsevation area to be monitored by RN's during and after her vaccine administration. After receiving her first dose of the Pfizer vaccine in her right deltoid, patient was communicating and laughing appropriately with staff with no signs of difficulty breathing A/O x3 at this time. Patient verbalizing feeling warm. Water offered to patient. Ice Pack provided. Approximately 7 minutes after vaccine administration patient had a visibly blank stare with no facial expression. Patient's body was then observed to start mildly shaking motion which staf then turned patient to her side. 911 called. Epinephrine 0,3mg administered as ordered per protocol to left thigh. VS taken , oxygen administered via rebreather mask at max amount. After approx. 2-3 minutes  patient opened her eyes and was slowly able to respond to some questions such as her name. Patient responded appropriately. Patient stated she had some numbness on her right side. She made good eye contact. Paramedics and fire department arrived and took her via gurney to ER.
Was up all night again; Asthma; Allergies which is worse this year; Nasal congestion; Coughing; Shortness of breath; Runny stuffed up nose; Cannot sleep all night; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of SLEEP DISORDER (Was up all night again), ASTHMA (Asthma), HYPERSENSITIVITY (Allergies which is worse this year), NASAL CONGESTION (Nasal congestion) and COUGH (Coughing) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma and Allergy.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SLEEP DISORDER (Was up all night again), ASTHMA (Asthma), HYPERSENSITIVITY (Allergies which is worse this year), NASAL CONGESTION (Nasal congestion), COUGH (Coughing), DYSPNOEA (Shortness of breath), RHINORRHOEA (Runny stuffed up nose), SLEEP DISORDER (Cannot sleep all night) and FATIGUE (Fatigue). At the time of the report, SLEEP DISORDER (Was up all night again), ASTHMA (Asthma), HYPERSENSITIVITY (Allergies which is worse this year), NASAL CONGESTION (Nasal congestion), COUGH (Coughing), DYSPNOEA (Shortness of breath), RHINORRHOEA (Runny stuffed up nose), SLEEP DISORDER (Cannot sleep all night) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. Treatment for the event include Inhaler, allergy medications.
On 6/2/22 chest started to burn so went to county test site and confirmed positive for COVID, then went to prompt care to receive Pfizer antiviral, which cleared burning and restored bi-pap events to normal.  on 6/10/22 developed fevers, chills, etc. took Tylenol; fevers increased to 102 on 6/13. Dr advised not COVID rebound and to go in. Went to ER where they determined I had pneumonia (though previously vaccinated) along with low sodium levels put on Zpack antibiotics; 6/19 back in ER once again with low sodium and pneumonia not cleared so placed on levofloxafin antibiotic for 5 days.
Information has been received from a nurse practitioner for the pregnancy Registry for GARDASIL concerning a 14 year old female patient with hypertension who on 13-OCT-2008 was vaccinated with her first dose of GARDASIL (Lot#660612/0229X) by intramuscular route and a dose of VARIVAX (lot and route not reported). Concomitant therapy included influenza virus vaccine (unspecified) and DTaP (unspecified). On 09-DEC-2008 the patient received her second dose of GARDASIL (Lot# 660612/0229X). As of 15-DEC-2008, the patient was eight weeks pregnant (LMP 20-OCT-2008, EDD 27-JUL-2009). The patient reported no symptoms. Follow up information has been received for a health care professional who clarified the patient's EDD of 27-JUL-2009 from the initial report. 09-DEC-2009, the patient received her second dose of GARDASIL and shortly after that the patient had a miscarriage. It was also reported that the patient had some irregular periods and got pregnant again (WAES# 1001USA03249). The patient did not have any GARDASIL between the pregnancies and will have her third dose when the patient returns to the office and it is confirmed that she is not pregnant. Additional information is not expected.
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION /ANOTHER VARIANT; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's concurrent conditions included ldl (low density lipoprotein), and triglycerides, and other pre-existing medical conditions included normally in good health. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported)at a frequency of 1 total, dose was not reported, administered on 21-MAY-2021 for prophylactic vaccination.  Concomitant medications included eicosapentaenoic acid ethyl ester for ldl, and triglycerides, and fenofibrate for ldl, and triglycerides.  On 03-JUL-2021, the subject experienced suspected clinical vaccination failure and suspected covid-19 infection / another variant. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from suspected covid-19 infection / other variant, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: 20210713929-covid-19 vaccine ad26.cov2.s-Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
systemic inflammatory response syndrome; falls/legs had given out from under her; This literature-non-study case was reported in a literature article and describes the occurrence of SYSTEMIC INFLAMMATORY RESPONSE SYNDROME (systemic inflammatory response syndrome) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.   LITERATURE REFERENCE:     The patient's past medical history included Hypertension and Diabetes.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SYSTEMIC INFLAMMATORY RESPONSE SYNDROME (systemic inflammatory response syndrome) (seriousness criterion medically significant) and FALL (falls/legs had given out from under her). At the time of the report, SYSTEMIC INFLAMMATORY RESPONSE SYNDROME (systemic inflammatory response syndrome) and FALL (falls/legs had given out from under her) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Blood culture: normal (normal) normal. In 2021, Body temperature increased: 39.1 (abnormal) 39.1 degree celsius. In 2021, C-reactive protein: 63.4 (Inconclusive) 63.4 milligram per litre. In 2021, Computerised tomogram abnormal: pulmonary nodule (abnormal) multiple pulmonary nodules measuring up to 1o1 cm. In 2021, Culture urine: normal (normal) normal. In 2021, Fibrin D dimer: high (High) 5267 ng/ml.. In 2021, Heart rate: 88 (normal) 88 BPM. In 2021, Positron emission tomogram: abnormal (abnormal) It showed uptake in the fat stranding posterior to the right deltoid,moderate uptake with in right axillary lymph nodes and diffusely increased uptake in spleen and no uptake in pulmonary nodules showing they are benign.. In 2021, Red blood cell sedimentation rate: 63.4 (Inconclusive) 63.4 mm/h. In 2021, Respiratory rate: 25 (abnormal) 25 breaths per minute. In 2021, SARS-CoV-2 test: negative (Negative) negative.     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.   Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Got flu shot on Wednesday, 10/06/21 Notes her arm is really red, softball size of redness Feels swollen and hot to the touch onset 10/07/21 did draw an outline around her redness, hasn't spread from there No fever, No Sob, No radiating pain up or down arm Did get benadryl this morning, seemed to help Icing as well to help with swelling and redness No discharge or drainage No tylenol or ibuprofen  Covid Vaccines-In left arms Did not have any reaction similar to the covid
DEATH; This spontaneous report received from a consumer via social media via a company representative concerned a patient of unspecified age, sex, 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 was not reported, 1 total, start therapy date was not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date it was reported that "Moms neighbor got the vaccine and died that night." On an unspecified date, the patient died from an unknown cause of death. It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0: 20220233703-COVID-19 VACCINE AD26.COV2.S-Death. The event(s) 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(s). Therefore, this event(s) is considered unassessable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Pt recv vax on 11/4/98; 30 min later pt exp unconsolable crying x 8 hr; pt to E.R.
miserable; felt like a truck hit them; fatigue; achy; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (miserable), MALAISE (felt like a truck hit them), FATIGUE (fatigue) and MYALGIA (achy) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 28-Feb-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 FEELING ABNORMAL (miserable), MALAISE (felt like a truck hit them), FATIGUE (fatigue) and MYALGIA (achy). At the time of the report, FEELING ABNORMAL (miserable), MALAISE (felt like a truck hit them), FATIGUE (fatigue) and MYALGIA (achy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact
At day 9, I started have itching, swelling and redness (size of a silver dollar) at the injection site.
had a flare up with her back problems; This is a spontaneous report from a contactable consumer (patient) via Pfizer. A female patient of an unspecified age received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- unknown) via an unspecified route of administration as 1st dose, single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unspecified date in 2021, patient had a flare up with her back problems before the 2nd dose on 05Feb. The outcome of the event was unknown.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Fever began 4/19. was 104 at ED, no temp take at home. Was at bd party. Was staring, large pupils, not responding ?lips turned blue. Breathing harder and faster. "Was tense and shaking" lasted 1 min total. Very tired for 1hr after. Taken to ER. Given rocephin/omnicef.
Pericarditis, inflammation of the pericardium around the heart; This is a spontaneous report from a contactable consumer who reported for herself, a 52-year-old female patient who received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EWO151), via an unspecified route of administration, administered in right arm on 01Apr2021 at 18:00 (at the age of 52 years old) as a single dose for COVID-19 immunization. The patient was not pregnant at the time of vaccination. The patient had no known allergies. The patient did not have COVID prior vaccination and was not COVID tested post vaccination. There were no medical histories nor concomitant medications. The patient previously received the first dose of BNT162B2 on 10Mar2021 at 06:00 PM (lot number: EN6206), at the age of 52 years old, administered in the right arm for COVID-19 immunization. The patient had no other vaccines in four weeks. The patient experienced pericarditis, inflammation of the pericardium around the heart on 14Apr2021 at 16:30. The event resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. It was unknown if treatment was received for the event. The outcome of the event was recovering.
Mom indicated headache,other symptoms immediately after vaccine and then developed "cellulitis like" symptoms at injection site.
This spontaneous report as received from a pharmacist via Bayer refers to a patient of unknown age who enrolled in a Market Research Program. On an unknown date the patient was vaccinated with a dose of PNEUMOVAX 23 (lot #, expiration date and route unspecified) 8 weeks after PREVNAR. The seriousness of adverse experience was unknown. Additional information is not expected because the reporter refused additional contact.
Headache, NauseaVomiting, Contracted COVID 19 virus. Tested positive 03/11/21 at facility. He was admitted to hospital. Narrative: Patient who completed the Pfizer vaccination on 01/26/21 with his second dose. Tested positive for COVID 19 at Medical Center on 03/11/21. He was admitted to hospital and spent two days in house. First dose was on 1/5/21, second dose 1/26/21