chrisvoncsefalvay/vaers-outcomes huggingface dataset:
While being on the contraceptive pill Junel FE ( six years now) light spotting started the day after the administration of the first dose of the vaccine which lasted for almost a week.  While being on the contraceptive pill Junel FE ( six years now) heavier spotting occurred immediately the day after the administration of the second dose of the pill. Still lasting.
Symptoms, when I woke up heaviness in chest area and Hoarseness. Haven't went to doctor yet but I did call, had to work. If not better by Monday will go to doctor.
No adverse affects reported; Nurse called reporting improperly stored VARIVAX was administered to patient on 18-MAY-2020; This spontaneous report was received from a nurse who refers to a patient of an unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions or allergies were not provided. On 18-MAY-2020, the patient was administered improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) for prophylaxis, lot # S012036, expiry date 17-APR-2021 (formulation, strength, dose, route of administration and frequency were not reported). Digital data logger was involved. The varicella virus vaccine live (oka/merck) (VARIVAX) was stored at temperature of 48.2 (units not provided) for 4 hours. There was no previous temperature excursion. No adverse effects were reported. No Product Quality Complaint (PQC) was involved.
I got a headache, fever (100.6 F), low back pain, short breath after 19 hours  later.  I knew those symptoms are normal. But I got a very bad chest pain on third day.  I fell a little better after half hour.
25AUG92 arm swollen & rec, hot to touch; t102-103 x 3 days; 1in lump x 1 wk; arm itched & hive like;
4/14/21-1am starts Fever, sweating, body ache, weakness,  intense head ache, nausea begin.  (Vomiting - once 3:30am) 4/15/21 1 am Symptoms Shift Still sweating, but headache is gone. Intense abdominal pain/throbbing  begins- no positions of comfort, etc. Nausea continues  6pm  Abdominal pain resolves, still nauseous, headache continues,  aggravated by movement of body or head, lights, etc.  4/16/21 Recent symptoms continue  4/17/21  11am, headache lessens , some mobility without aggravating  1:30 file report. No solid food consumed since 8:00 pm 4/13/21 due to nausea
Reports reaction appeared as a 3.5 inch radius red itchy edematous wheal around injection site. Area remained red and itchy for 5 days, decreasing daily.
UTI - burning, urgency, etc. phone visit on 5/20:  Prescribed antibiotic and pyridine. 5/23: symptoms resolving
Approximately 4 days after getting booster shot started having slight dizziness. Still having a little now. Have not seen my Doctor. Unless it gets worse, not going to the Doctor.
Chest tightening and pressure on chest with random arrhythmia ?skipped beats?.  Adverse reaction started 03/15/21 -10/15/2021, 7 months of intermittent myocarditis/endocarditis symptoms
Breakthrough case of Covid. 12/28/2021 sx began with me waking up at 04:00AM with the worst pain in my life, I soaked in the tub for like 30 minutes and I was okay. 12/29/2021 I woke up with the same pain in my legs, I soaked in the tub for about 30 minutes and I was okay. Later in the day runny nose, congestion, cough, tightness in my chest. I knew something was not right. 12/30/2021 I went to urgent care having the same sx. They did a rapid test and a long test, lung x-ray it all came back okay. The PA thought I had an upper raspatory infection. Told to take over the counter stuff for your cough. 12/31/2021 went back to the urgent care, had another x-ray and was prescribed steroids (prednisone). I think in about 3 to 5 days I was feeling better as far as the congestion and cough, but I had a lingering chest pain that I have had ever since. I saw a cardiologist and he said everything looks good, I have a second opinion scheduled at the end of the month with another cardiologist.
Hair loss following first dose, got worse after the second dose. Bald spot and thinning hair.  I have not seen a doctor about this yet. My scalp looks healthy and this was a fairly sudden event with no precedent ever.
J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 3/22/2021 CAD (CORONARY ARTERY DISEASE) WO ANGINA J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 3/22/2021 ACUTE HYPOXEMIC RESPIRATORY FAILURE J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 3/22/2021 ATHEROSCLEROSIS OF AORTA J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 3/22/2021 AV BLOCK, MOBITZ TYPE 2
Swollen, painful lymph node in left armpit lasting 3 days.  Rash on left arm around injection site, approximately 4 inches long and 2 inches wide, lasting 3 days.
DEATH Narrative: UNCLEAR WHY PATIENT WAS HOSPITALIZED AS LIMITED INFORMATION IN RECORD
VAERS completed because of being Tested positive for COVID-19 infection 14 or more days after being fully vaccinated. 1st 03/03/21dose Lot#EN6202 2nd dose 03/24/21,lot#ER8727 Diagnosed covid positive:08/08/21 Symptom onset:08/07/21 Exposure:work Symptoms:fatigue, runny nose,headache
A consumer report has been received. The report concerns a 1 year old, male consumer, who had been receiving Nasal FLUMIST. The reporter stated that her 18 month old son received FLUMIST which started on 04-DEC-2012. She stated the pediatrician's office called her to notify her that he should have received the injection instead of the nasal spray. MD office told her there was nothing else that needed to be done. The outcome of the event of my 18 month old son received FLUMIST is unknown. The report was considered to be non-serious.
An 11 year old received a booster dose of the Pfizer 12+ COVID vaccine in error. The child does not have any adverse reactions.
Cancer; Interchange of vaccine products; This spontaneous case was reported by a physician and describes the occurrence of NEOPLASM MALIGNANT (Cancer) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: Pfizer COVID-19 vaccine (Dose 2) and Pfizer COVID-19 vaccine (Dose 1). Past adverse reactions to the above products included No adverse event with Pfizer COVID-19 vaccine and Pfizer COVID-19 vaccine.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced NEOPLASM MALIGNANT (Cancer) (seriousness criterion medically significant) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products). At the time of the report, NEOPLASM MALIGNANT (Cancer) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. The patient was just diagnosed with cancer before getting the second booster. No treatment information was provided.  Company comment: This spontaneous case concerns a 69-year-old male patient, with no reported medical history, who experienced the unexpected serious (medically significant) event of Neoplasm malignant that occurred on an unknown date after receiving the mRNA-1273 vaccine as 3rd dose. Onset latency cannot be assessed as the vaccination date and onset date of event were not provided. It was reported that patient was diagnosed with cancer before the second booster. Clinical course and treatment details were not reported. The outcome of event was unknown. On unknown dates, patient received 2 doses of Tozinameran vaccine as primary series prior to mRNA-1273 vaccine (Interchange of vaccine products noted). The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2022-636246 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 29-Aug-2022: Non significant follow-up contains reporter's  updated address.; Sender's Comments: This spontaneous case concerns a 69-year-old male patient, with no reported medical history, who experienced the unexpected serious (medically significant) event of Neoplasm malignant that occurred on an unknown date after receiving the mRNA-1273 vaccine as 3rd dose. Onset latency cannot be assessed as the vaccination date and onset date of event were not provided. It was reported that patient was diagnosed with cancer before the second booster. Clinical course and treatment details were not reported. The outcome of event was unknown. On unknown dates, patient received 2 doses of Tozinameran vaccine as primary series prior to mRNA-1273 vaccine (Interchange of vaccine products noted). The benefit-risk relationship of mRNA-1273 is not affected by this report. US-MODERNATX, INC.-MOD-2022-636246:
I had the chills during the night and a severe headache. My left arm pit(axilla )is tender and sore .
RED, SWOLLEN, FEELS HOT WHEN TOUCH 3-4 CM LUMP ON RT ARM.
Patient has pain in left arm for 2 weeks with a score of 8/10 on pain scale. Pain runs from injection site to elbow
Administration error: 15 year old M given 1st dose of Pfizer vaccine two weeks before his 16th birthday. Patient completed series with second dose of Pfizer vaccine 1 week after 16th birthday. No adverse effects reported.
12/29-developed a severe sore throat; Wednesday, 12/30/2020 with runny nose and nasal congestion. She continues to be congested Narrative:  12/29-developed a severe sore throat; Wednesday, 12/30/2020 with runny nose and nasal congestion. She continues to be congested
Information has been received from a nurse referring to a patient of unknown age and gender.      On 05-JUN-2017, the patient was vaccinated with improperly stored VARIVAX (lot # M033212, expiration date 13-JUL-2018; dose and route were unknown) for prophylaxis. The vaccine reconstituted with properly stored sterile diluent (lot # and expiration date were unknown). No adverse effects were reported. Data logger was involved. The vaccine was stored under -14 Celsius degree to -10 Celsius degree for 4 hours 3 minutes. Previous temperature excursion was -14 Celsius degree to -10 Celsius degree for 5 hours 13 minutes. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1707USA009387:
On 12/25/00 the patient had symptoms of hives on pelvis, back of legs; it worsened, and his feet swelled. She went to the ER. The patient was given Benadryl and steroid injection at 6 PM. On 12/27/00, hives on pelvis, and back of his legs again. Later that evening after he went to see his own private doctor his lips started swelling. On 12/29/00, his doctor prescribed Prednisone tablets and Zantac for 10 days. By 12/30/00, his symptoms had resolved. On 12/07/00, the patient had an Influenza injection by an outside vendor. Unable to get any information from the vendor at the present.
2 generalized tonic clonic seizures approx 4 hrs post vax; not febrile seizures;
Approximately 4 hours after shots, lethargy, double vision, pale, 100 degree fever, decreased pulse. Next day, redness and swelling at injection site, right deltoid, Pneumovax.
This spontaneous report was received from a physician refers to a multiple patients of unknown age and gender. No concurrent condition or medical history was reported. On an unknown date in October 2015, the patients were vaccinated with improperly stored dose of GARDASIL (dose and route of administration not provided). No concomitant therapy was reported. No adverse effects were reported. The outcome of the event was unknown. No product quality issue was involved. This is one of the several reports from same reporter link. Additional information has been requested.
7 Days Later Admitted to hospital for P o2  of 85    SOB    Diagnosis Bilateral Pulmonary Emboli
This spontaneous report was received from a registered nurse and refers to two patients of unknown age and gender. No information regarding the patients' pertinent medical history or concurrent conditions was reported. On an unknown date(s), the patients were vaccinated with improperly stored doses of GARDASIL 9 (lot reported as M000326, expiration date: 14-OCT-2019; dose and route of administration were not reported). The vaccine was stored in temperature of 47 degrees Fahrenheit for 42 minutes. It also underwent previous temperature excursion (47 degrees Fahrenheit) for 33 hours. Digital data logger was used to detect the temperature excursion. No product quality complaint (PQC) was involved. Lot number M000326 is an invalid lot number for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast). Additional information has been requested.
First symptom on Wednesday 12/10/14 was irritation on Left forearm, felt like raw skin or a scratch. On Thursday morning 12/11/14 drying after the shower the skin was sensitive. From there it slowly spread over whole body creating the sensation of a sunburn with hyper-sensitive skin. Sensitivity to touch, cold, frequent chills, progressing to muscle soreness and joint stiffness everywhere. Mostly in legs and back. Final symptom has been head pressure and inner ear pain and extreme scalp sensitivity.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) 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: "Leukaemia" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN; PEPCID [FAMOTIDINE]. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Results, notes: Covid rebound. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: Other medication in 2 weeks product (Atorvastatin and Pepcid). No known allergies.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201400554 Same patient, different product and event;
Discovered Intra-uterine Fetal Demise.  Probably occurred 1 week prior. 11/05/09 Medical records received for DOS 9/22/09-10/20/09. OB/GYN notes.  Patient noted reduced fetal activity. No FHT found on exam in office.  Fetal demise at 14 wks 4 days. Uterine fundal height 13 wks. LMP 08/07/09. G3, P2, Proceeded with D&C.
Patient was given an expired vaccine Hep B vaccine lot UO19135 dated 11/22/2022. Doctor and Office Manager notified.  Patient returned 5/25 for vaccine in date.
My son, who was nearly 2 years old at the time of my vaccination and  who was breastfed, started vomiting 2 days after my vaccine. This lasted for about 2 days and went hand in hand with nausea and headache I experienced. About 10 days after the second dose of the vaccine, my son vomited again for about 3 days. I experienced headache and nausea at the same time.
Rebound symptoms; This spontaneous case was reported by an other health care professional and describes the occurrence of REBOUND EFFECT (Rebound symptoms) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment.    Patient had many unspecified medical history or concurrent conditions.  Concurrent medical conditions included Drug allergy (The patient had allergy to unspecified drug.).   On 08-May-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (Oral) at an unspecified dose. On an unknown date, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced REBOUND EFFECT (Rebound symptoms). At the time of the report, REBOUND EFFECT (Rebound symptoms) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient's race was reported. The patient was taking other unspecified medications/products within 2 weeks of starting COVID-19 treatment. Device Date : 23-May-2022
kidney cancer; 1st dose 01-22-21 lot 043l20a and 2nd dose 03-05-21 lot 013a21a; This spontaneous case was reported by a patient and describes the occurrence of RENAL CANCER (kidney cancer) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 059m21a, 037f21a, 013a21a and 043l20a) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Jun-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose 01-22-21 lot 043l20a and 2nd dose 03-05-21 lot 013a21a). In November 2022, the patient experienced RENAL CANCER (kidney cancer) (seriousness criterion medically significant). The patient was treated with PEMBROLIZUMAB (KEYTRUDA) ongoing since an unknown date for Kidney cancer, at an unspecified dose and frequency. At the time of the report, RENAL CANCER (kidney cancer) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose 01-22-21 lot 043l20a and 2nd dose 03-05-21 lot 013a21a) outcome was unknown.            No concomitant information was reported. The patient had kidney cancer and stated that they cut all the cancer out. It was reported that patient was on immunotherapy with the drug KEYTRUDA for kidney cancer and wanted to know if it was okay for him to take another COVID shot. No treatment information was provided. Company comment: This spontaneous case concerns a 70-year-old male patient, with no medical history reported, who experienced the unexpected and serious (medically significant) event of RENAL CANCER, approximately 5 months after the fourth dose of mRNA-1273 vaccine. Patient was treated with pembrolizumab. Inappropriate schedule of vaccine administered was also reported since he received the first and the second dose of mRNA-1273 vaccine 42 days apart. No further information for medical review. Patient´s age could be a risk factor for renal cancer. The benefit-risk relationship of the mRNA-1273 is not affected by this report.
Worst headache I?ve ever had (8 out of 10 pain scale), could not sleep due to the headache, very lightheaded, entire body ached (could barely move), eyes hurt, highest fever temp 102.8, nausea (at times I thought that I may have to puke). These symptoms lasted all night, but felt better in the morning. These symptoms were like COVID but x5. When I had the COVID-19 virus, my symptoms were not as bad as yesterday?s adverse effects from the vaccine. At 3 AM, I was considering going to the hospital and I have never been hospitalized before. I could barely open my eyes since the headache was so bad.
Presented to the ED with shortness of breath with 77% O2 saturation on room air Patient was given oxygen Received monoclonal antibodies, dexamethasone, remdesivir, singulair Used BIPAP then intubated Patient went into circulatory shock and given IV vancomycin for bacteremia and levophed Patient was extubated and pressors discontinued Passed away on September 6, 2021 at 1220pm.
On the eighth day following the vaccination, I developed a large red circle at the injection site.  It is approximately 2 inches long and wide, warm to the touch and slightly itchy.  The skin feels lightly elevated and slightly tender to touch.  In the past 24 hours it has remained unchanged.
Pain at site; progressing within 8 hours to upper arm pain, erythema, edema of posterior and anterior left arm below injection site.
Almost instantly after receiving my vaccine, I started feeling "extra heartbeats" and it was making me cough. I have an apple watch that can tell if I'm in A-fib. I knew that something wasn't right because of the extra heartbeats. I stayed for about 30 minutes. I walked out to the nurse's station because I still had this problem. Someone told me that it's been 30 minutes so I could leave. I drove myself home. I contacted my doctor about a few days later. At first, they told me that I could take Metoprolol that I had. They asked me to come in and have blood work done and an EKG. The EKG showed that everything was okay, but my doctor informed me that there are other patients that have experienced similar symptoms/adverse event.
9/12/06-Local reaction-redness at site. On 9/13/06 had been to clinic for achy, sore arm, stiff neck on right side, and headache. No fever. 9/15/06-woke up with 6 red, pruritic papules which appeared to be going towards vesicular. Later in day 6 more lesions. They were not yet scabbed over. Started on Acyclovir 200mg, 4 tabs QD x 5 days.
Given shots at noon on 9/28. Woke up the morning of 9/29 with eyes swollen shut, face red, chest pain. Went to MD, put on Benadryl 50mg every 4-6 hrs. In clinic 9/30, face still red, swelling gone, states tongue feels "heavy".
Woke up at 4:30 am with severe arm pain.  Advil and Tylenol took along with ice pack.  Pain improved with movement in morning on Tuesday.  At noon, fatigue, body aches, and temp of 99.6.  Took more Advil and Tylenol with symptoms improving.  7pm on Tuesday symptoms returned with increased severity: headache, body aches, fatigue, temp 100.5.  More Advil and Tylenol taken.  Fatigued on Wednesday and feeling better on Thursday with mild fatigue.
Patient with history of diabetes type II, CHF, colon cancer, and ESRD on dialysis.   He was brought to the ED by EMS on 12/14/22 for evaluation of weakness, shortness of breath, and coughing. Notably, a few days prior he underwent chemotherapy and had a full dialysis run. In, the ED, a COVID PCR test was done which returned positive. Patient was admitted 12/14/22 - 12/27/22 with discharge diagnoses including failure to thrive secondary to metastatic malignancy, hypoxic respiratory failure (appears more consistent with fluid overload and anemia), and suspect COVID pneumonia with superimposed bacterial CAP. Patient has received the primary COVID vaccine and one booster.
Headache, Arthralgia, Fever, NauseaVomiting, Site discomfort, fatigue Narrative:
Within 24 hours of vaccine admin the infant developed V&D Vomiting resolved w/in 48 hours diarrhea still occuring 7 days later