chrisvoncsefalvay/vaers-outcomes huggingface dataset:
after her first dose of the Covid-19 vaccine, given in her right arm, that her arm was swollen and the swelling went down some/was more swollen after the first dose; after her first dose of the Covid-19 vaccine, given in her right arm, that her arm was swollen and the swelling went down some/was more swollen after the first dose; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 83 year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm right, administration date 22Feb2021 (Lot number: ENG200, Expiration Date: 30Jun2021) at the age of 83 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "high blood pressure" (ongoing), notes: she has been having high blood pressure almost her entire life; "right arm was swollen", start date: Dec2020 (ongoing), notes: prior to the first dose of the Pfizer Covid-19 vaccine due to a  car accident 7 years ago.; "arm was broken in the car accident" (unspecified if ongoing); "arm was broken in the car accident" (unspecified if ongoing); "blood pressure" (unspecified if ongoing). Concomitant medication(s) included: COZAAR taken for blood pressure abnormal, stop date: 13Mar2021. The following information was reported: PERIPHERAL SWELLING (non-serious), CONDITION AGGRAVATED (non-serious), outcome "not recovered" and all described as "after her first dose of the Covid-19 vaccine, given in her right arm, that her arm was swollen and the swelling went down some/was more swollen after the first dose". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient had no prior vaccinations (within 4 weeks). Clinical course: Patient reported that after her first dose of the COVID-19 vaccine, given in her right arm, that her arm was swollen and the swelling went down some. Patient stated that her right arm was swollen prior to the first dose of the Pfizer COVID-19 vaccine due to a  car accident 7 years ago. Patient reported that her arm was broken in the car accident and that a cast was placed on her arm versus surgical intervention. Patient reported that beginning in Dec2020 her right arm was a little swollen and that it was more swollen after the first dose of the Pfizer COVID-19 vaccine. Patient reported that her right arm is still a little swollen. The event did not require an emergency room or Physician office visit. The patient did not undergo any relevant tests. The patient also take a concomitant medication olmesartan medoxomil (BENICAR) started on 14Mar2021 and ongoing for blood pressure.  No follow-up attempts are possible. No further information is expected.
Adverse Event NOS; Accelerated Heart Rate; Chest Pain; Lightheadedness; Initial Report Received on 14-Sep-2022   This report was received from Novavax concerning a patient reported that she, a 41-year-old female (race and ethnicity unknown) received an unknown dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization on 10-Aug 2022 and a dose 2 of a Novavax COVID-19 vaccine on 19-Aug-2022, and then experienced chest pain, dizziness, and increased heart rate.  Medical history, allergies, and concomitant medications were not reported.   On 16-Jul-2022, the patient received dose 1 of the Novavax COVID-19 vaccine, adjuvanted 10 µg/mL administered intramuscularly (Lot #, expiration date, NDC #, and injection site not reported).  On 19-Jul-2022, the patient had a positive COVID 19 SARS-CoV-2 test and COVID infection.  On 10-Aug-2022, the patient received an unknown dose of a hepatitis B dose of HEPLISAV-B (Lot # 935841; expiration date, NDC #, injection site, and route of administration not reported).   On 19-Aug-2022, 10 days after receiving the HEPLISAV-B injection, the patient received dose 2 of the Novavax COVID-19 vaccine, adjuvanted 10 µg/mL administered intramuscularly (Lot # 430IMF0l3; expiration date, NDC #, and injection site not reported). On the same date (19-Aug-2022), three hours after the Novavax COVID-19 vaccine, the patient experienced lightheadedness, increased heart rate to 100  120 beats per minute (bpm) (baseline heart rate was 80 bpm), and chest pain located in the center of the chest.   On 20-Aug-2022, 11 days after receiving the HEPLISAV-B vaccine and 2 days after receiving the Novavax COVID-19 vaccine, the patient went to the emergency room (ER) for continued symptoms, which lasted for several days. Details of the ER visit were not reported.  At the time of report on 15-Sep-2022, the dizziness was reported as recovered/resolved and the increased heart rate and chest pain were recovering/resolving.   No additional information was provided.  The causal relationship between Novavax COVID-19 vaccine and the reported events was assessed as possible by the manufacturer.  Company comment: The company assessed the events as non-serious.; Sender's Comments: The company assessed the events as non-serious.
This is an instance of breakthrough COVID-19 disease after which death occurred.   The individual was vaccinated with the Moderna product on 01/20/2021 and 02/17/2021. I do not have lot numbers available to me.   The invidudual reported a symptom onset date of 11/16/2021. They tested positive for COVID-19 via PCR test on 11/22/2021. They died on 12/04/2021. The individual was diagnosed with pneumonia and COVID-19 is listed on the death certificate.
swollen; itchy; red; warm to touch; lump; This spontaneous case was reported by a physician and describes the occurrence of PERIPHERAL SWELLING (swollen), PRURITUS (itchy), ERYTHEMA (red), SKIN WARM (warm to touch) and AXILLARY MASS (lump) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, the patient experienced PERIPHERAL SWELLING (swollen), PRURITUS (itchy), ERYTHEMA (red), SKIN WARM (warm to touch) and AXILLARY MASS (lump). The patient was treated with HYDROCORTISONE at an unspecified dose and frequency. At the time of the report, PERIPHERAL SWELLING (swollen), PRURITUS (itchy), ERYTHEMA (red), SKIN WARM (warm to touch) and AXILLARY MASS (lump) outcome was unknown.        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.
Headache, NauseaVomiting, chills, low grade fever, arm soreness
pt recv vax 27MAR96 & 1APR96 pt devel t103.5 R & presented to MD;pt was documented as having OM;the reporter felt that the OM was not r/t therapy w/varicella vax;
pt recv vax & p/20min pt c/o itch;did not report until next day had a dime size red mark @ site;no other sx reported, no tx
On Thursday, June 8th, 2023, pt. received her 4-month vaccinations, which included DTaP+HepB+IPV, Hib, PCV13, and Rotavirus (oral). Two days after the vaccination, on Saturday, June 10th, my spouse and I noticed a firm lump on her upper left thigh. I distinctly remember the doctor mentioning that redness, swelling, and fever could be common side effects after receiving a vaccine. However, it is uncommon for a lump to appear in a specific area of the body. I promptly contacted the doctor's office via email and phone to express my concerns. The nurse advised me to apply cold compression and instructed me to call the office and schedule a sick visit if the lump persists after two to three days. Consequently, I have scheduled an appointment with pt.'s primary pediatrician on Monday, June 20th, at 4:40 pm.
Patient developed low grade fever, chest pain, breast pain, skin "on fire" sensation, and elevated blood pressure.
The vaccination caused me to have an early menstrual cycle. The vaccination resulted in my cycle being 15 days instead of 30 days.
MMR given 06/14/00. Fever occurred 06/19. 06/20 vomiting, severe apnea requiring mouth to mouth. Subsequent hospitalization for rule out of sepsis. Fever of 104.
This spontaneous report as received from a registered nurse via a company representative refers to an unspecified number of unspecified patients. No information regarding the patients' pertinent medical history, concurrent conditions or concomitant therapies was provided. On unknown dates, the patients were vaccinated with doses of improperly stored VAQTA lot # M002268, expiration date 20-SEP-2017 (dose, route and site administration were not reported). There were no adverse effects reported. This is one of several reported received from the same reporter. Additional information has been requested.
Narrative:  PATIENT WAS IMMUNIZED IN A TIMELY MANNER 3-6-21 AND 3-26-21 WITH PFIZER MRNA VACCINE. PATIENT TESTED POSITIVE FOR COVID AFTER PRESENTING TO ER WITH WORSENING SOB DOIG MINIMAL EXERTION. PATIENT WAS ADMITTED FOR HYPOXIA (ON BASELINE O2 AT HOME D/T IPF) 02 NEEDS INCREASED IN HOSPITAL UP TO 6 L WITH ACTIVITY. HE WAS TREATED AND RECEOVERED AFTER LENTHY HOSPITAL STAY.
Flu like symptoms. Temperature fluctuations between 97.5 to 101 in 8 minutes. Wanted to crawl out of my skin. Dizziness. Excessive sweating. Nausea.
Information has been received from a physician, via a company representative, concerning a 17 year old female patient, who on approximately 20-Oct-2007 ("a month ago") was vaccinated IM with the first dose, 0.5 ml, of Gardasil (lot # not provided).  After an unknown duration of time, the patient experienced stomach pain and vomiting.  Subsequently, the patient recovered from stomach pain and vomiting (duration not specified).  The patient sought unspecified medical attention.  The patient's 23 year old sister also experienced the events as described above, when vaccinated with Gardasil (WAES #0711USA04192).  Further information is not available.
Tested positive for Covid-19. Symptoms are like cold. Fatigue. Slight fever.; Tested positive for Covid-19. Symptoms are like cold. Fatigue. Slight fever.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 74-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Lot number: 32030BD), in left arm and on 20May2022 as dose 4 (booster), single (Lot number: FJ9943) at the age of 74 years, in right arm for Covid-19 immunization; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history was not reported. There were no concomitant medications. The patient did not receive any other vaccine in four weeks. No Other medications were received in two weeks of Covid vaccine. The patient was not diagnosed with Covid prior vaccination.  The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 15Jun2022 at 20:30, outcome "unknown", COVID-19 (medically significant) with onset 15Jun2022 at 20:30, outcome "recovering" and all described as "Tested positive for Covid-19. Symptoms are like cold. Fatigue. Slight fever.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 antibody test: (15Jun2022) Positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of covid-19.  Follow-up attempts are completed. No further information is expected.
Approximately 2 hours post vax, the pt became nauseous, fatigued, experienced left arm soreness and reportedly decreased LOC with increased respiratory rate. The pt also experienced a skin rash and dry mouth, left arm soreness primarily at elbows.
Fever- 12 hours Headache -ongoing, starting day after vaccination Shortness of Breath- 2 weeks Tinnitus- ongoing, starting day after vaccination
Patient expressed concerns over itchiness. Patients arm showed signs of mild rash with redness and raised texture. Benadryl 50 mg administered and patient monitored for 15 additional minutes. Patient expressed symptoms were getting better and patient was subsequently discharge with the instructions to call back an provide additional context if anything else were to hepen.
Covid-19 infection post vaccination; This literature-study case was reported in a literature article and describes the occurrence of COVID-19 (Covid-19 infection post vaccination) in a 68-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.   LITERATURE REFERENCE: Development of COVID-19 infection in transplant recipients after SARS-CoV-2 vaccination. Transplantation. 2021;105(9):e104-6     The patient's past medical history included Kidney transplant (16 months). Concurrent medical conditions included Immunosuppression. Concomitant products included TACROLIMUS, MYCOPHENOLATE MOFETIL and PREDNISONE for Immunosuppression.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (Covid-19 infection post vaccination) (seriousness criterion hospitalization). At the time of the report, COVID-19 (Covid-19 infection post vaccination) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered COVID-19 (Covid-19 infection post vaccination) to be possibly related.    This case related to patient 2 as per article and initial symptoms included were Cough, fatigue.  No treatment was reported for the patient.  Outcome of the event was reported as alive  Company Comment: This is a literature report of mild COVID-19 in a kidney immunosuppressed patient of 68 years old, 4 days after receiving the second dose of the product. Doses dates are not provided, thus appropriateness of product administration schedule is not assessable. Based on the mechanism of action of mRNA-1273 causal association between the event of COVID-19 infection and mRNA-1273 is assessed as not applicable.   This case was linked to MOD-2021-303225, MOD-2021-303228, MOD-2021-303227, MOD-2021-303226 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 02-Sep-2021: Follow up received by safety 2-Sep-2021 included an Email with FTA received from Regulatory Authority team and does not contain any new information.; Sender's Comments: This is a literature report of mild COVID-19 in a kidney immunosuppressed patient of 68 years old, 4 days after receiving the second dose of the product. Doses dates are not provided, thus appropriateness of product administration schedule is not assessable. Based on the mechanism of action of mRNA-1273 causal association between the event of COVID-19 infection and mRNA-1273 is assessed as not applicable.
MD1 on 1/2/21: Post inoculation, pt developed hives.  States the itching progressed > was evaluated by dermatologist who advised she take fexofenadine hydrochloride 4x a day and then levocetirizine 4x a day.  Minimal improvement; was put on hydroxyzine by PCP on 2/7/21; MD2 on 1/30/21: Post inoculation of 2nd dose, reports worsening hives.  Rash has now progressed to her face and she also reports swelling around her eyes and mouth.  Pt has not received steroids yet because of concern for the efficacy of the vaccine, but she is now requesting steroid medication.  Pt had chills & temp of 99.4F; VS BP 115/69, Temp 99.4F, Pulse 112 -> 65, RR 12, SpO2 98% on RA; Pt treated with NS 1 L IV fluid bolus for dehydration, famotidine 20mg IV, methylprednisolone 60mg IV, and diphenhydramine 50mg IV. On re-evaluation, patient is resting comfortably and is in no respiratory distress.  HR has improved to 65 BPM and pt's hives have improved.  Pt has no oropharyngeal edema.  Lungs remain clear. Pt instructed to take medications as directed & f/u with immunology.
Tested positive for Covid-19 on 9/4/2021.  Admitted for generalized weakness
Fine unraised pink rash immediately after Gardasil injection on her right deltoid. Rash resolved in 10 minutes. No other complaints. #3 Gardasil - No prior reactions.
Chills, hot flashes, full-body sweats, nausea, vertigo, dizziness, tunnel vision, disorientation
Pt received dose at 0828 and after about 15 minutes reported symptoms of: Face numbness, lip tingling, heart racing.  A rash was also noted on her chest and perhaps to her right eye.  Heart rate was 99 BPM and Pulse ox was 99%.  Pt was transported to the ED for evaluation.  Upon call back to  ED they also stated pt reported her tongue was also affected (not swollen, but either numb or tingly).
Prior to getting Covid vaccines, bloodwork was checked and all results showed healthy, stable WBC - and no sign of Leukopenia/Neutropenia.  Following Covid vaccine by about 1 month, I started to feel sick, hair was falling out, chills, fatigue, etc.  Had bloodwork retested by hematologist/oncologist, and bloodwork showed Leukopenia/Neutropenia WBC-3.6 , low RBC count, and elevated MCV.  My son, who doesn't have my blood disorder had a physical for college.  His bloodwork also showed low WBC- 3.7, and he lives in the dorms.  He had the Covid vaccines same day and location as me.
DIZZY; LIGHTHEADEDNESS; PAIN UNDER THE LEFT ARM; CHILLS; SORENESS AT INJECTION SITE; FEVER; GENERALIZED ACHING; This spontaneous report received from a patient concerned a 28 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient does not have any allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 041A21A expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 01:30 for prophylactic vaccination. No concomitant medications were reported.  On 10-APR-2021, the subject experienced generalized aching. On 10-APR-2021, the subject experienced soreness at injection site. On 10-APR-2021, the subject experienced fever. On 11-APR-2021, the subject experienced chills. On 13-APR-2021, the subject experienced dizzy. On 13-APR-2021, the subject experienced lightheadedness. On 13-APR-2021, the subject experienced pain under the left arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from generalized aching on 12-APR-2021, chills on 11-APR-2021, soreness at injection site on 10-APR-2021, and fever on 13-APR-2021, and was recovering from dizzy, lightheadedness, and pain under the left arm. This report was non-serious.
It started out only in my feet and legs, but now has spread to my arms and hands. A tingling pricking sensation that I have no control over. I notice it more at night but now it is in my arms and it seemed to be just at night. But now it is lasting through the morning.
Reporting a faulty syringe. Patient was poked on the left arm and immediately the vaccine started spilling out upon immunizing. No reactions reported from this site, except minimal injection site soreness after 15 minute waiting period. Patient was given a full dose later due to clinical judgement, patient did not receive the first immunization/dose. Patient was monitored over 15 minutes. Followed up with her and reported minimal soreness on arms.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-month-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 74 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: "hypothyroid" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 18Feb2023, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (18Feb2023) Positive; (Feb2023) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19 included administration of Paxlovid from 09Feb2023 to 13Feb2023 (as reported). The patient had no known allergies. It was reported that the patient received Pravastin from 01Jan2023 to 10Feb2023. Covid test came back positive after being negative 5 days after without symptoms of fever or pain or cough, just Sneezing.   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.
Site: Swelling at Injection Site-Medium, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Additional Details: Patient went to er after given benedryl and her face and eyes swelled up as well as her arm.
Initial event was soreness at site which resolved on its own within a few days.  2 days after receiving vaccine, I began having an allergy reaction  to the same brand N95 that I had been utilizing since the beginning of the pandemic. Symptoms are swollen cheeks and welts , sudden itchiness at the site of my mask placement. The reason for this report is a sudden onset of excruciating and debilitating pain throughout my body specifically pain of my right shoulder radiating down my sprightly arm. I have been receiving testing and treatment for ongoing neuropathy due to Longhauler syndrome, however This recent pain is so debilitating, I spend most of my time in bed.  I have been experiencing chills then profuse sweating.  I also so fatigued, I sleep much of the day.  I have been having episodes of tachycardia with chest tightness which has increased since after having the vaccine. I also become short winded on exertion. I?ve been waking up in a panic and sweating.