chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Sore Arm; tested positive (after both doses); Pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore Arm), MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) and COVID-19 (tested positive (after both doses)) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     No relevant medical history was provided.  Concomitant products included PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE] and SERTRALINE for an unknown indication.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 10-Oct-2021. On 07-Apr-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant). On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore Arm) and COVID-19 (tested positive (after both doses)). On 07-Apr-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) had resolved. At the time of the report, PAIN IN EXTREMITY (Sore Arm) and COVID-19 (tested positive (after both doses)) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test positive: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.  Company Comment: This case concerns a 28-year-old, female patient with no relevant medical history, who experienced the unexpected events of maternal exposure during pregnancy, Covid-19 and pain in extremity. The patient received the first dose of the Moderna Covid-19 vaccine at unknown age of gestation. The event pain in extremity occurred also on an unknown date. The benefit-risk relationship of the vaccine is not affected by this report.   This case was linked to MOD-2021-253146 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 13-Oct-2021: Follow up received on 13-OCT-2021 includes reporters contact details, changes from the initial version include update in coding of event, start date, stop date and outcome of event.; Sender's Comments: This case concerns a 28-year-old, female patient with no relevant medical history, who experienced the unexpected events of maternal exposure during pregnancy, Covid-19 and pain in extremity. The patient received the first dose of the Moderna Covid-19 vaccine at unknown age of gestation. The event pain in extremity occurred also on an unknown date. The benefit-risk relationship of the vaccine is not affected by this report.
Dizziness and HTN; Monitor B/P and Neurological checks Q 4 hours x 24 hours
Nine days following shot a large red spot appeared at the injection site on arm. I thought it Was a spider bite, but realized it was at the exact spot where my shot was given; This is a spontaneous report from a contactable consumer, the patient. A 56-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 right arm on 31Mar2021 at 15:30 (at the age of 56-years-old), as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient did not have any allergies to medications, food or other products. Concomitant medications included bio identical hormones (MANUFACTURER UNKNOWN) from an unknown date for unspecified indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 07Apr2021 at 15:00, the patient experienced nine days following shot a large red spot appeared at the injection site on arm. The patient thought it was a spider bite, but realized it was at the exact spot where the shot was given. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event a large red spot appeared at the injection site on the arm, the patient thought it was a spider bite, but realized it was at the exact spot where the shot was given was not resolved at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
About one week after booster, blood pressure went very low  for a few days. I felt dizzy and fatigued.  The blood pressure spike to 205, 107.  I went to ER. Saw my doctor and he added a beta blocker. Within two days, pulse went to 48 so went to health center where I work. Blood pressure was 220/127. They added a diuretic. Within two day, blood pressure drop below a 100/60. Stopped taking diuretic so blood pressure is around 105/. Blood pressure continues to go very low and then high. . In February. Have an appt with cardiologist in February.
Hospitalization: Admitted 8/15/2022; discharged 8/19/2022. Presentation to the ED: Shortness of breath; decreased oxygen saturation while on room air. Treatment: Patient admitted and treated with corticosteroids and oxygen therapy. Discharge: Home.
Fever approximately 102 on 10/5/17, seen in office 10/6 with fever, fussy, vomited x1. 10/9/17 - Rash started on abdomen, trunk, back, buttocks, face.
Tenderness in axillary lymph node area and in cervical lymph node area.  Lasted about three days.  Did not know if this was related to the administration of the vaccine.  However on 06/16/2015 was given vaccine #2 in the series and woke in the night with shooting pains down to her fingers on the same side as vaccine site with swelling redness and heat at vaccine site.
Information has been received from a 74 year old female concerning himself, with a history of chickenpox (when was little) and sulfonamide allergy, who on 08-JAN-2008 was vaccinated with ZOSTER vaccine (Lot # 658396/0967U), 0.65 ml, subcutaneously. Concomitant therapy included SIMVASTSTIN (MSD). The caller stated that in November 2008, the patient developed shingles in the left side of her scalp after having been vaccinated with the vaccine. Her physician prescribed VALTREX. The patient sought unspecified medical attention. At the time of the report, the patient was recovering. Additional information has been requested.
This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. It was reported that the VAQTA vials were "cloudy, instead of clear" causing to the patient to miss a dose on 13-FEB-2017 (intramuscular for prophylaxis) lot/batch M040421 expiration date 26-MAY-2017. No adverse effects reported. Additional information has been requested.
relapse of Multiple Sclerosis; This spontaneous case was reported by a consumer and describes the occurrence of MULTIPLE SCLEROSIS RELAPSE (relapse of Multiple Sclerosis) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Multiple sclerosis, Blood pressure high, Strength loss of, Walker user and Bladder incontinence. Concomitant products included OCRELIZUMAB (OCREVUS), FUROSEMIDE (LASIX [FUROSEMIDE]), CARVEDILOL, POTASSIUM, OXYBUTYNIN, OLMESARTAN and FAMPRIDINE (AMPYRA) for an unknown indication.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MULTIPLE SCLEROSIS RELAPSE (relapse of Multiple Sclerosis) (seriousness criterion medically significant). At the time of the report, MULTIPLE SCLEROSIS RELAPSE (relapse of Multiple Sclerosis) had resolved.            Treatment information was not provided by reporter.  It was reported that events occurred 1.5 days after patient received the vaccination and resolved after 1.5 days after started.  This case refers to a 61-year-old female patient with a medical history of Multiple sclerosis, Blood pressure high and Bladder incontinence, who experienced the unexpected event of Multiple Sclerosis Relapse at an unspecified time after exposure to Moderna COVID-19 Vaccine. No causality assessment was provided by the reporter. Rechallenge was reported as not applicable. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report.; Sender's Comments: This case refers to a 61-year-old female patient with a medical history of Multiple sclerosis, Blood pressure high and Bladder incontinence, who experienced the unexpected event of Multiple Sclerosis Relapse at an unspecified time after exposure to Moderna COVID-19 Vaccine. No causality assessment was provided by the reporter. Rechallenge was reported as not applicable. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report.
when I got the second vaccine I lost the use of my legs for 20 minutes; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 21-year-old male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for Covid-19 Immunization. The following information was reported: LOSS OF CONTROL OF LEGS (medically significant), outcome "unknown", described as "when I got the second vaccine I lost the use of my legs for 20 minutes".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
broke out w/chicken pox on 19JUN;eyes starting swelling shut;pt taken to local MD 21JUN who gave eye ointment;eyes cont to swell & took pt to ER who did nothing;pt to regular pediatrician who dx early stage cellulitis
Information has been received on 10-APR-2018 from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. During 2010, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route, by a physician, for routine adult health maintenance and the intended purpose for the prevention of shingles. The vaccine did not prevent shingles as intended. The patient subsequently contracted a persistent strain of herpes zoster, the very virus the ZOSTAVAX is intended to prevent. During 2016, the patient was treated by a physician for a vesicular outbreak, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Extreme flu like symptoms 2 anaphylactic episodes, headache, lethargy, ringing in ears.
This spontaneous report as received from a nurse via company representative refers to a 55 year old female patient. The patient did not have pertinent medical history, drug allergies and concomitant medications. On an unspecified date in 2016, reported as last week, the patient was vaccinated with ZOSTAVAX, 19400 PFU, 1 shot (1 DF) (route, lot # not reported) and subsequently "developed soreness and burning at the injection site. The patient also had "a tiny itchy papule rash on her left shoulder, which spread down her arm and to her wrist". No lab test was performed. The patient sought medical attention in the nurse's office and was treated with an unspecified antihistamine. No product quality (PQC) issue involved. The outcome of injection site pain, injection site burning, rash pruritic and rash popular were unknown. The causality assessment was not provided. Additional information has been requested.
tested positive for COVID-19; lack of drug effect; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (tested positive for COVID-19) and DRUG INEFFECTIVE (lack of drug effect) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011D21A and 939676) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Jan-2022, the patient experienced COVID-19 (tested positive for COVID-19) and DRUG INEFFECTIVE (lack of drug effect). At the time of the report, COVID-19 (tested positive for COVID-19) and DRUG INEFFECTIVE (lack of drug effect) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Jan-2022, SARS-CoV-2 test: positive (Positive) positive tested on morning..         No concomitant medications were reported.  Treatment medications were not provided by the reporter. Reporter is going through a divorce and suspects their spouse (patient) provided them with a counterfeit vaccine card.  Company Comment - This spontaneous case concerns a 46 year old male patient with no relevant medical history, who experienced the unexpected events of COVID-19 and vaccination failure. The events occurred 4 months and 13 days after the second dose of mRNA-1273 vaccine. Based on the current available information, the mRNA-1273 does not contain a virus capable of causing infection. The rechallenge was not applicable. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report. Sender's Comments: This spontaneous case concerns a 46 year old male patient with no relevant medical history, who experienced the unexpected events of COVID-19 and vaccination failure. The events occurred 4 months and 13 days after the second dose of mRNA-1273 vaccine. Based on the current available information, the mRNA-1273 does not contain a virus capable of causing infection. The rechallenge was not applicable. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.
"I" was having a jittery episode, like the kind that happens when "I" take a steroid.  It lasted until about 2a/could not be still; I was exhausted; 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 left arm on 03Mar2021 at 07:45 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. Medical history included sleep apnea, anxiety, depression, overweight and allergy to sulfa drugs(sulfonamide allergy). Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included fluoxetine (MANUFACTURER UNKNOWN) taken for an unknown indication from an unknown date and unknown if ongoing. On 03Mar2021 the patient was fine until 22:30. Then while patient was in bed, patient was having a jittery episode, like the kind that happens when patient took a steroid. It lasted until about 02:00. The patient heart was not racing, was not fast breathing. but patient could not be still and though patient was exhausted, could not rest. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event jittery episode and exhausted, could not rest was recovered on 04Mar2021.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
hearing loss; pneumonia; Chronic body pain; This spontaneous report as received from a lawyer, regarding a case in litigation and refers to a female patient of unknown age. The patient's relevant medical history, drug reactions/allergies and concomitant medication were not reported. On or about 26-FEB-2013, the patient was vaccinated with zoster vaccine live(ZOSTAVAX) for routine health maintenance and for its intended purpose: the prevention of shingles (strength, route, dosage schedule, lot number and expiration date were not reported).    On an unknown date, the patient experienced hearing loss, chronic body pain and pneumonia. As a direct and proximate result, the patient's symptoms have resulted in physical limitations not present prior to using Merck's product. Plaintiff also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition.   As a result, the patient sustained severe, serious, progressive, permanent, and incurable personal injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The outcome of deafness, pain and pneumonia was not recovered.   The reporter considered deafness, pain and pneumonia to be related to Zoster Vaccine Live(ZOSTAVAX).     Upon internal review, deafness and pneumonia were considered medically significant events.
PT RECEIVED INFLUENZA VACCINE, AND AS ADMINISTRATOR WAS ATTEMPTING TO ACTIVATE THE SAFETY GLIDE FEATURE OF THE SYRINGE, THE ADMINISTRATOR WAS STUCK BY THE NEEDLE IN THE RIGHT FIRST FINGER.
Two blood clots formed in my pancreas along with acute pancreatitis. I ended up in the hospital from Jan 22-28. On IV pain meds, fluids, and blood thinners. I have never had a blood clot in my life and now I have two. I went home on blood thinners and pain meds. I was cleared of my first occurrence with pancreatitis in Nov 21 and now I got it back with blood clots and necrosis again. I have been eating healthier and working out so I feel this a side effect of the booster shot.
Pfizer COVID vac #1 - 1/14/21 - #EL3247; Pfizer COVID vac #2 - 2/4/21 - EEL9261; pt lives in a residential facility; had a positive COVID test on 12/21/21, prior to admission into the facility; DNR; slow to recover from COVID; on O2 supplementation; pt expired in the residential facility
Within 4 hours baby had a fever of 102.9 and was very fussy. There was a little local reaction only slight tenderness. He had diarrhea and decreased oral intake.
Breakthrough case admission after 2 vaccines  Pfizer 2/12/21 Lot# EL9265;  Pfizer 3/5/21 Lot# EN620
Sick from COVID vaccine; Still difficult to recover from physical activity like grocery shopping; Pain from covid vaccine; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Sick from COVID vaccine), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Still difficult to recover from physical activity like grocery shopping) and VACCINATION SITE PAIN (Pain from covid vaccine) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis and Ankylosing spondylitis.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced ILLNESS (Sick from COVID vaccine), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Still difficult to recover from physical activity like grocery shopping) and VACCINATION SITE PAIN (Pain from covid vaccine). At the time of the report, ILLNESS (Sick from COVID vaccine) had resolved, LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Still difficult to recover from physical activity like grocery shopping) had not resolved and VACCINATION SITE PAIN (Pain from covid vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were reported. No treatment medications were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
After vaccine patient was seated in waiting area, patient started falling to the ground and was caught by bystander, patient talking "I'm okay", diaphoretic, pulse 80, BP 140/p. Patient a&ox4, reports he had not eaten yet today, wearing multiple layer/heavy jacket in warm indoor environment. Patient was given juice, denies any pain from fall, denies CP, denies SOB, denies difficult swallowing, no rash/hives present, no nausea/vomiting. Patient reports feeling a warm sensation flush through his body, and feeling himself start to pass out, reports that the same thing happened during a routine blood draw. Patient remained on site for 20 min, patients skin cool/dry, with healthy color, had patient stand for a moment before leaving, patient denies any dizziness/lightheadedness. Patient left with significant other, with plan to have something to eat when he got home. Directed patient to call 911 if he started feeling lightheaded/dizzy, or had new onset chest pain/pressure, back pain, radiating arm pain, SOB, difficulty swallowing or other allergic reaction symptoms.
Sore arm, swelling at injection site, injection site hot to the touch, fatigue, low grade fever, body aches. Advil used as treatment.
Parent had the patient give the description: The next morning, I had sore left side/left side of neck. Later on that day, I was feeling my neck and I felt a giant lump on the left side of my neck. I thought that I had slept on it wrong. Later on, it wouldn't go away - even with massage. It was painful. It caused disturbance, I wasn't comfortable when I was sleeping. It had gotten bigger the next morning. Our doctor said that it was lymph nodes and it was a response of immune system to injection. To make sure, I'm getting an ultrasound. It has gone done but I still notice another smaller lump there still as well. (The two lumps are side by side.)  For the pain and swelling, the doctor prescribed me ibuprofen. This has calmed it down. It was still a little swollen - about two weeks after. But it's going down little by little. I still feel it, but it's now very small.