chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Non-itchy hives all over trunk and chest, neck, partially neck and arms lasting two days; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 27Apr2021 (at the age of 50-year-old) as a single dose for COVID-19 immunisation. Medical history included hives. Prior to the vaccination, the patient was not diagnosed with COVID-19.  It was unknown whether the patient had any allergies to medications, food, or other products. Concomitant medications included ethinylestradiol, levonorgestrel (LESSINA) as birth control from an unknown date. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 29Apr2021 at 12:00 the patient experienced non-itchy hives all over trunk and chest, neck, partially neck and arms lasting two days. The patient had this reaction about 6 times within the last 15 years, though patient was uncertain of what triggers it. No therapeutic measures was taken as a result of the event. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the event non-itchy hives all over trunk and chest, neck, partially neck and arms lasting two days was recovering at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Per Dr. -localized skin reaction to flu vaccine, no anaphylaxis, and no presentation of flu vaccine reaction.
Narrative:  93yo M with hx of Pathological Fracture, right femur, subsequent encounter for fracture with routine healing, Chronic Kidney disease, Stage 4(severe),Contact with exposure to other viral communicable diseases, Malignant melanoma of skin, Type II diabetes Mellitus with diabetic chronic kidney disease. Vitamin D deficiency, Hypertensive heart and chronic kidney disease with heart failure and stage 1 through stage 4 chronic kidney disease, Unspecified chronic Kidney disease, Heart failure,Constipation,Gout,Presence of urogenitalimplants died on 7/3/2021. He had received covid vaccinations on 1/15/21 & 2/12/21. Pt resided in a nursing home. Likely death not related to covid vaccinations given pt's advanced age & medical history & date of death > 90 days from last vaccine given.
After dose 1 on  3/18/21, extreme fatigue for two weeks and arm hurt for a couple days at shot site. After dose 2 on 4/8/21, weak, chills and body aches all over for one day on 4/9, and arm hurt for a couple days at shot site.
Started with sore arm; progressed to inability to move arm. Fever, headache, body aches, chills, cough, fatigue, and a sharp, stabbing intermittent pain in upper right chest, which can best be described as heart pain (upon exertion). I also had trouble using my hands. Loss of strength and dexterity. Fingers somewhat in curled position. I was sick for almost 2 weeks. The last symptoms to resolve were the chest pain and cough. Cough lasted longer than the 2 weeks but I cannot say how long. I did not report because a hospital trip was pointless. Our hospitals were swamped with at least 6 hour ER wait times. I attributed my response to my immune system recognizing the vaccine ingredients and doing it's job by producing antibodies.
After receiving my second dose I was experiencing chest pain and had a fever over 100 degrees Fahrenheit for over four days. Three days after my second dose I decided to my local urgent care where they ran tests, including a covid test, and everything came back negative. Recently, I?ve been experiencing debilitating migraines. Out of nowhere it feels like someone hit me in the head with a hammer in one spot. Feels like it?s right behind my eyes most times.
Fever began roughly 11 hours after vaccine was administered. Fever lasting roughly 29 hours, treated with Tylenol and Advil. Possible cellulitis also began roughly 11 hours after vaccine was administered. Redness and tenderness continue to spread over the next two days. I was prescribed antibiotic on 2/11/2021
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 58-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Oct2022 at 09:30 as dose 5 (booster), single (Lot number: GH9693) at the age of 58 years, in left 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), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Type 1 diabetes (controlled)" (ongoing). Concomitant medication(s) included: NOVOLOG; LISINOPRIL; NIFEDIPINE; HYDROCHLOROTHIAZID; METOPROLOL; ATORVASTATIN. 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: (2022) Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical coarse: The patient had no known allergies. He received Paxlovid (anti-viral) for COVID 19 treatment from 18Nov2022 to 22Nov2022.
Excruciating headache, 101.8 fever after 800 mg Advil. Fever did not break for 24 hours, then went up again two days later -3/1/21 at 3:30pm. Again 101.3.  Headache lasted 24+ hours. Used ice packs on top, back and eyes for minimal relief. Advil did not lower temperature or aid in headache relief.
SARS-COV-2 IGG ANTIBODY TEST RESULT (1.49); COVID-19 TEST POSITIVE; PREFILLED SYRINGES WAS KEPT OUT OF THE REFRIGERATOR FOR MORE THAN 2 HOURS; This spontaneous report received from a consumer concerned multiple patients (employees). The patients weight, height, and medical history were not reported.  The patients received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported, 1 total, for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  It was reported that the physician was providing antibody test named as test to all the office staffs and immunosuppressed patients 4 to 6 weeks after receiving the Janssen Covid-19 vaccine. Test report 1.49, which was borderline nothing. The company, tested regularly with the nasal swabs. It was reported many of the employees received the Janssen COVID-19 vaccine and then tested positive for COVID-19. According to the physician, the patients functioned as if they never got the vaccine at all. It was also reported that the physician knew that the vaccine did not have to go in the freezer, but it could only be out of the fridge for 2 hours. The physician suspected that the people got vaccines that were in prefilled syringes and kept out of the refrigerator for more than 2 hours, thus rendering them useless. He wanted these patients to be able to get a booster of Pfizer or Moderna as the patients who received Pfizer and Moderna produced strong results. On an unknown date, COVID-19 nasal swab was done. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) positive and COVID-19 antibody test (NR: not provided) negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the covid-19 test positive, sars-cov-2 igg antibody test result (1.49) and prefilled syringes was kept out of the refrigerator for more than 2 hours was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint. The suspected product quality complaint has been confirmed to be void: N based on the PQC evaluation/investigation performed. This case, from the same reporter is linked to 20210545141 and 20210545098.; Sender's Comments: V0 20210544684-COVID-19 VACCINE AD26.COV2.S-SARS-COV-2 IGG antibody test result (1.49). 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.
Flu like symptoms same thing last year along with right foot neuropathy; high fever worsening headache; next days following right foot became swollen and beet red, very hot swollen can't feel cold on foot.
Received the COVID-19 vaccine 12/19/2020 and felt great the next few days with zero symptoms.  About 3-4 days later I felt some chest discomfort especially when taking a deep breath in.  This occurred on both the front side and back side of chest.  This continued for the next 5-7 days.  Kept experiencing pain with deep breaths and my exercise tolerance was diminished.  When I would hike up a small incline I felt I was not getting enough air and was a bit winded.  Finally made an e-visit with my healthcare provider on 12/28/2020 after 5-7 days of symptoms.  Knowing I work in healthcare my provider asked if my pain felt like, "pleuritic chest pain" and I think that is a spot on description of how it felt.  Based on my symptoms he told me the most likely diagnosis is a mild case of pericarditis and prescribed me ibuprofen 400 mg by mouth 3 times daily for a few days.  After ~36 hours of ibuprofen I'm feeling 80-90% better but still have some discomfort with deep breaths or exertion.
The same day the client was vaccinated, she developed nausea.  Has had nausea, headaches, and occasional vomiting.  Also had clear liquid dripping from nose beginning 11/29/19.  Mom took client to Dr. for follow-up.  Mom reports MD thought drainage could be spinal fluid but was not sure.  Client has been on home-bound.  Drainage has stopped but still having nausea and headaches.  Mom reports client with hx of depression and anxiety.  Was on home-bound for a time last year and had similar symptoms and had a CT scan at that time.  Spoke with Mom today and encouraged her to take client back to PCP.
BLURRED VISION; FEELING GENERALLY UNWELL; LOW GRADE FEVER; HEADACHE; This spontaneous report received from a patient concerned an 18 year old female. 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: Unknown) dose was not reported, administered on 14-JUL-2021 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 JUL-2021, treatment medications included: paracetamol. On 14-JUL-2021, the subject experienced blurred vision. On 14-JUL-2021, the subject experienced feeling generally unwell. On 14-JUL-2021, the subject experienced low grade fever. On 14-JUL-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from blurred vision, low grade fever, headache, and feeling generally unwell. This report was non-serious.
her eyes looked off extra large and a kind of redness around the orbit; Groggy and eyes looked off; This is a spontaneous report received from a contactable other health care professional (parent) . A 17-years-old female patient received of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: not reported) via intramuscular route of administration in her left arm on 23Mar2021 at 14:00 (at the age of 17-years old) as dose 1, single for COVID-19 immunization.  Medical history included fainting and orthostatic hypotension.  Patient concomitant medication included The birth control medications). Prior to vaccination, the patient was not pregnant, not diagnosed with COVID-19, did not receive any other vaccines within 4 weeks. Since the vaccination, has the patient has not been tested for COVID-19. On 23Mar2021 at 14:15, the patient experienced groggy and patient eyes looked off, extra-large and a kind of redness around the orbit -near the skin and the reporter reported as that she called an on-site employee emergency medical technician (EMT) facilitating the 15 minutes post shot. The events resulted in doctor or other healthcare professional office/clinic visit. The patient received treatment for the reported events. On an unspecified date, the patient underwent lab tests which include blood pressure(bp) and pulse oximeter (pulse ox) measurement with unknown result. The outcomes for the events redness of eyes and groggy was recovering at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
now has something that looks like a genital wart /the possibility of getting human papillomavirus (HPV); she received the vaccine series after the age of 45; This spontaneous report as received from a consumer refers to a female patient, of unknown age. There was no information about the patient's medical history, concurrent conditions or concomitant medication.  On an unknown date, the patient was vaccinated 3 months after turning 46 year old  with the vaccine series of  hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) for prophylaxis (doses, route of administration, lot number and expiration date were not reported). The patient called inquiring about the possibility of getting human papillomavirus (HPV) after taking the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9).  On an unknown date, she had something that looked like a genital wart that it had recently appeared.It was reported that the patient had not been diagnosed with genital wart at this time as she had not seen her physician yet for this. No treatment was given for the adverse event. She received the vaccine series after the age of 45-year-old and possible development of HPV after getting the vaccine.  The outcome of anogenital warts was reported as not recovered. Causality of the event of human papillomavirus (HPV) and genital wart was not reported,
Patient developed intussusception 7/15/11 and admitted. Reduced by Barium enema required x 3. Sx began 7/14/11 with fussiness and spitting up more and by next day developed frankly bloody stool.
7-10 days after receiving MMR & TDAP developed redness and swelling of hands and progressed to ankles with warmth and fevers of 102 degrees and bilateral conjunctivitis.
PT CAME INTO CLINIC 1 WEEK AFTER RECEIVING THE FLUAD AND PPSV23 VACCINES IN THE LEFT ARM.  PT HAD OBVIOUS EDEMA, TENDER TO THE TOUCH AND VERY WARM AROUND VACCINATION SITES.  IT WAS EVIDENT WHERE THE SHOTS WERE GIVEN (1 INCH APART) AS EACH VACCINE SITE WAS THE MOST RED, SWOLLEN AND TENDER. THE REDNESS SPREAD APROX 1 INCH AND A 1/2 TO 2 INCHES FROM THE SITE.   PT STATED THAT THE NIGHT OF THE VACCINATIONS HER ARM BEGAN TO SWELL AND THE FOLLOWING DAY SHE HAD A FEVER OVER 100 DEGREES F.   SHE STATED SHE TALKED TO A NURSE OF THE PHONE FROM THE CLINIC SUNDAY NIGHT (15TH NOV) AND THE NURSE QUESTIONED HER IF HER ARM WAS TWICE THE SIZE OF THE UNAFFECTED ARM,  SHE SAID NO, SO SHE DID NOT COME IN.   PT SAID SINCE THEN HER FEVER HAS REDUCED ALMOST BACK TO HER NORMAL TEMP.   PT'S ARM IS VISIBLY LESS SWOLLEN AS DESCRIBED FROM THE FIRST NIGHT BY PATIENT.   A SMALL KNOT WAS NOT FELT HOWEVER HER ENTIRE DELTOID HAD EDEMA.   PT WAS ADVISED TO CONTINUE MONITORING AND TAKING HER 500 MG TYLENOL, RUBBING THE VACCINATION SITE, ALTERNATING HEAT AND COLD PACKS,.  SHE WAS INSTRUCTED THAT IF IT CONSISTED PAST ONE MORE WEEK TO CONSULT HER DOCTOR.   PT STATED SHE DID NOT USUALLY RECIEVE MORE THAN ONE VACCINE AT A TIME AND USUALLY SPACED THEM OUT.   SHE ALSO RECEIVED THE SHINGRIX VACCINATION IN HER RIGHT DELTOID (UNAFFECTED OTHER THAN PRIOR SORENESS AFTER THE VACCINE)  IT WAS DISCUSSED THAT DUE TO HER RECIEVING THE SHINGRIX VACCINE 3 WEEKS PRIOR TO THE FLU AND PPSV23 VACCINES, HER IMMUNE SYSTEM COULD BE REACTING AND RECONGNIZING ALL THREE VACCINES, WHICH COULD HAVE OVERWHELMED HER SYSTEM.  PT WAS INFORMED TO BEGIN GETTING ONE VACCINE AT A TIME OR TO MAKE SURE ONLY ONE VACCINE WAS GIVEN IN EACH ARM.
Chest pain, irregular heart rate, dyspnea, palpitations, myoclonus, dizziness, fatigue & cough with sudden onset
seizures occuring approx 1 hr p/vax; mom states no MD visit was made; pt called MD for guidance; high fever 104-105 precipitated mom thinks; states MD told probably should suggest DT;
NOSE BLEED; SLIGHT HEADACHE; SLUGGISHNESS; This spontaneous report received from a patient concerned a 57 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included gluten allergy.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, and batch number: 043A21A expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the subject experienced sluggishness. On 07-APR-2021, the subject experienced slight headache. On 15-APR-2021, the subject experienced nose bleed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sluggishness, and slight headache on 07-APR-2021, and had not recovered from nose bleed. This report was non-serious.
Instantly felt warm and slightly dizzy as soon as the shot was administered. As the day went on, I felt very lethargic and tired. Lost strength throughout the day. Random fingers on both hands throughout the day would go numb for a few minutes at a time. In the evening, flu like symptoms set in. I felt very hot, while I was very cold. I could not sleep for longer than 2 hours at a time, despite being unbelievably tired. I got up twice during the night and vomitted. Around 3 AM, I woke up and my left arm, from my elbow down to my fingertips was completely numb. I got up and walked around, moved my arm vigorously, however, the numbness would not go away. I eventually fell back asleep after 6 AM, and woke up again around 7:20 AM. At that time, the numbness in my left arm had gone away. It was hard to get up to be active on Saturday, the day after. I spent most of the day laying down, feeling sick to my stomach, still very cold, and very tired, with no energy or strength. Around 5 PM, I started to feel better, and by 7:30 PM, I felt close to normal.   Throughout this past week, I have felt tired a majority of the time. I am sleeping 1.5-2 hours longer than I normally sleep, I lack the strength, energy, power, and endurance I had prior to the vaccine, however, that all seems to be marginally getting better each day. I am still experiencing  my fingertips on both hands going numb for short periods, from time to time, as of today, 6 days post vaccine.
Systemic: Fainting / Unresponsive-Mild, Systemic: Headache-Mild, Additional Details: Pt fainted about 5 minutes after injection for less than 1 min. Did not require EMS call. Pt sat for 20 minutes before leaving and drank water. Slight headache also reported. Pt states this has happened about 10 years post vaccination - most likely panic attack, not a fan of needles.
herpes zoster lt lateral antebrachial cutaneous nerve distribution (C5-C6);
Slight fever, chills, fatigue, shaking, headache across forehead. All lasting 2 days then 1 more day slowly back to normal.
Horrible cramps similar to abortion pain that started the next morning after my vaccine and still after 3 weeks of getting the vaccine I continue to have these cramps.
Vaccine given 11/9/11, developed pain, redness, swelling and hives to left arm on 11/10/11. Pt seen 11/11/11 and is resolving.
admitted on 12/31/21, due to acute resp failure with hypoxia d/t covid.  Tested positive for COVID on 12/27/21.  Patient is a 76 y.o. male w/ pmh significant for ESRD on HD however, still makes some urine, HRN, COPD, morbid obesity, hypothyroidism who presented to the ED w/ sob.  Symptoms started about 1 week prior to presentation on 12/24/2021.  Associated symptoms have included cough, chest pain with coughing, shortness of breath, chills, myalgias, headache, nausea, vomiting and diarrhea, as well as a change to his taste and smell.
Chest pain; A spontaneous report was received from a non-health care professional concerning a 51 year old, female patient while participating in the mRNA-1273 Emergency use program and experienced chest pain.  The patient's medical history included allergy to hydrocodone bitartrate /acetaminophen. No relevant concomitant medications were reported.   On 23 DEC 2020, prior to the onset of symptoms, patient received the first of two planned doses of mRNA-1273 intramuscularly in the left arm for the prophylaxis of COVID -19 infection.She was monitored for 15 minutes. After this, she returned to her desk and approximately 10 minutes later she experienced chest pain. The pain lasted five to six minutes and the patient went to the Emergency room (ER). At the ER they performed an electrocardiogram. No treatment information was provided.  The event, chest pain, was considered resolved on 23 DEC 2020.  Action taken with planned second dose of mRNA-1273 in response to the event was not provided.; Reporter's Comments: This case concerns a female patient who experienced the event of chest pain, occurring about 30 minutes following administration of the first dose of mRNA-1273 vaccine. Based on the limited available information, a definitive assessment with regards to a drug: event-causal association cannot be provided at this time. However, due to the temporal association between the onset of the event and the administration of the drug, a causal relationship cannot be excluded. Hence, the event is assessed as possibly related to mRNA-1273.
Patient's arm was swelling, and painful. She was developing a fever. For treatment she was taking TYLENOL, icing the arm, and BENADRYL at night to help with the swelling.
Arm hurt through this past Tuesday. Woke up this morning with shoulder/arm very swollen and painful at injection site.
a low grade fever; Initial information received on 02-Sep-2020 regarding an unsolicited valid non-serious case received from a consumer or non health care professional.  This case involves a patient (unknown demographics) who experienced a low grade fever (pyrexia), while received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  Medical history, concomitant therapy, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date (3 weeks ago), the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot number, dosing details and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed non-serious a low grade fever (pyrexia) (Unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  No laboratory data was reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, patent had not recovered from pyrexia.  There will be no information available on batch number for this case.