chrisvoncsefalvay/vaers-outcomes huggingface dataset:
upset stomach; chills;  Permitted by caller to collect details of call. Caller referenced this case number: MOD-2021-122758. (Current case now crosslinked with Case # MOD21-089750).  Caller compying with request to return call & provide an email address. She does not have an email address. This agent did confirm her mailing address & added minimal update to vaccine information.  "I got the shots of the Moderna Covid-19 vaccine in Jan2021 & Feb2021. It was at the end of the month for both of them."  1st dose: Near end of Jan2021 Lot: unknown Exp: unknown inj site: left arm Age: 86yo DOB: 15May1934 Pregnant: No  2nd dose: Near end of Feb2021 Lot: unknown Exp: unknown inj site: left arm Age: 86yo DOB: 15May1934 Pregnant: No  Consent given for Safety follow up/contact.
Within 24 hours after having my vaccine, I had headaches, chest pressure, congestion, fever, loss of taste, fatigue and smell and body aches.  When I caught COVID-19 February 25, 2023, I had all of the same symptoms I had for after my vaccine, but for eight weeks long. I still have some residual coughing. My taste and smell are finally starting to come back. I had a chest infection form as well and had to cough up blood. I also have chronic congestion. I take a nasal spray to try to keep the coughing from getting extreme.
the first day I had a sore arm. the second day I felt ok when I woke up until about 8 pm I was feeling dizzy, hard to catch my breathe, and tired. I struggled at work, but made it through my shift. I was pale, dizzy, sweaty. The next day I had itchy eyes and throat.  Eyes were red. I went to urgent care and was tested for Covid-19 and was negative.  two weeks this continued, chronically tired. my doctor finally put me on steroids ,and after finishing them I was feeling better.
Patient was vaccinated on Sunday and had purple hands Sunday night. Tuesday patient reported a rash over the entire upper body. Also experiencing fever and chills
This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient. A 56-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Nov2021 as dose 2 (booster), single (Lot number: 301458A) at the age of 56 years, in left arm for Covid-19 immunisation; Janssen Covid-19 vaccine (JANSSEN COVID-19 VACCINE), on 08Apr2021 as dose 1, single (Lot number: 42A21A), in right arm for Covid-19 immunisation. The patient's relevant medical history included: "borderline type II diabetes" (unspecified if ongoing); "genetic hyperlipidemia" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 07Apr2022, outcome "unknown" and all described as "I was infected on 03Apr; tested positive by rapid test 07Apr". The patient underwent the following laboratory tests and procedures: Polymerase chain reaction: (Apr2022) Ct of 20.6; SARS-CoV-2 test: (07Apr2022) Positive. Therapeutic measures were taken as a result of Covid-19. Clinical course: The patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment. 1st dose of Paxlovid evening of 07Apr; last dose Paxlovid 11Apr. Clinical signs 05Apr-08Apr sore throat, fatigue, muscle aches, cough, no fever. Clinical signs improved 09Apr and by last day of treatment single, residual cough. Residual cough lingered thru/out week of 10Apr not other clinical signs. 18Apr saw return of ILI thought to be allergies. Symptoms progressed & at home test 18Apr confirmed COVID positive. Since patient was a virologist & program officer, contacted colleagues on 19Apr and arranged to have samples taken for analyses on 20Apr for Ab, T cell, virus titer, confirmation infection, & virus sequencing. PCR confirmatory test results has Ct of 20.6. The patient signs of disease include heavy, frequent, nonproductive coughing w/ some mucus; heavy rhinorrhea, headache. No fever with either infection event. CBC & clinical chem. normal. Taking OTC Dayquil during "relapse". No follow-up attempts are possible. No further information is expected. Sender's Comments: Based on the information provide and plausible temporal association, the causality between BNT162B2 and events cannot be completely excluded.
rapid heart beat; Out of breath; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Out of breath) in a 35-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.     No Medical History information was reported.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2021, the patient experienced DYSPNOEA (Out of breath) (seriousness criterion medically significant). On an unknown date, the patient experienced TACHYCARDIA (rapid heart beat). At the time of the report, DYSPNOEA (Out of breath) had not resolved and TACHYCARDIA (rapid heart beat) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, Heart rate: increased (High) Rapid heart beats. On an unknown date, Myocardial necrosis marker: normal (normal) bloodwork returned normal showed no elevated cardiac enzymes..         No concomitant medication details were provided. No treatment information was mentioned. It was reported that patient received his second Moderna Covid-19 vaccine 4 weeks after his first Moderna Covid-19 vaccine. Patients Mother states that her son was not diagnosed with myocarditis or pericarditis. After receiving his second Moderna covid-19 vaccine in April 2021 patient was out of breath, experienced a rapid heart beat and felt as though he was experiencing a heart attack. Cardiac Lab values, electrocardiogram, cardiac test, cardiac enzymes were performed. The bloodwork returned normal. The patient would be going to cardiac computed tomography positron emission tomography scan on 13 Oct 2021.  Company comment -This case concerns a 35-year-old, male patient with no relevant medical history, who experienced the serious event of dyspnoea. The date of onset was not reported, neither vaccination date. The rechallenge was not applicable as no additional dose is expected to be given, and no details were provided about the first dose. The benefit-risk relationship of Spikevax is not affected by this report.   This case was linked to MOD-2021-350433 (Patient Link).; Sender's Comments: This case concerns a 35-year-old, male patient with no relevant medical history, who experienced the serious event of dyspnoea. The date of onset was not reported, neither vaccination date. The rechallenge was not applicable as no additional dose is expected to be given, and no details were provided about the first dose. The benefit-risk relationship of Spikevax is not affected by this report.
I received my first injection of the COVID-19 vaccine on 12/28/2020 and the second dose on 01/12/2021. Starting  Friday February 5, I developed severe itching on my back that occurred during sleep only. The itching continued for the next several nights. I had to remove my bra in order to obtain any sleep. After removing the bra, the itching eventually stopped. I tried several bras, but all caused itching at bedtime only. Now, itching is occurring on other parts of my body. Hives and itching have developed on my back, chest, inner thighs and both hands. The itching is relieved by applying lotion. My skin is super sensitive to elastics (in most bras) and other items. I'm only reporting this just in case other people have experienced the same sensitivities. I don't believe the vaccine caused the itching and hives; but instead just hastened or exacerbated something already in my body.
SOB, itching, coughing, red rash on chest, arm and face. Treated with Akid, Singulair, Prednisone and Allegra.
might have breast cancer; I had a bad mammogram/showed I have a mass; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 13Oct2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BREAST CANCER (medically significant) with onset 2021, outcome "unknown", described as "might have breast cancer"; BREAST MASS (non-serious) with onset 2021, outcome "unknown", described as "I had a bad mammogram/showed I have a mass". The patient underwent the following laboratory tests and procedures: mammogram: she had a mass, notes: She had a bad mammogram.  Clinical course: she was supposed to take the second dose on the 1st. she had a bad mammogram. It showed she have a mass and she need more screenings and they couldn't get me a date until the 18th and I am leaving the country on the 20th. I rescheduled for the 8th. Can she go past that date10/13 was her first dose. In the clinical study, the second dose was allowed to be given 19-23 days after the first dose. The CDC has provided some interim considerations stating individuals who receive the second dose up to 4 days before or at any time after the recommended date can be considered fully vaccinated.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Inflamed; Swollen and red where I got shot, closer to my elbow swollen like baseball; Swollen and red where I got shot; Very sore; My face felt like I had couple of shots of Novocain; My cheeks and teeth felt very numb; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (My face felt like I had couple of shots of Novocain), HYPOAESTHESIA (My cheeks and teeth felt very numb), VACCINATION SITE INFLAMMATION (Inflamed), VACCINATION SITE SWELLING (Swollen and red where I got shot, closer to my elbow swollen like baseball) and VACCINATION SITE ERYTHEMA (Swollen and red where I got shot) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No adverse event history). Concomitant products included ANASTROZOLE (ARIMIDEX) for an unknown indication.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, the patient experienced SWELLING FACE (My face felt like I had couple of shots of Novocain) and HYPOAESTHESIA (My cheeks and teeth felt very numb). On an unknown date, the patient experienced VACCINATION SITE INFLAMMATION (Inflamed), VACCINATION SITE SWELLING (Swollen and red where I got shot, closer to my elbow swollen like baseball), VACCINATION SITE ERYTHEMA (Swollen and red where I got shot) and VACCINATION SITE PAIN (Very sore). On 15-Feb-2021, SWELLING FACE (My face felt like I had couple of shots of Novocain) and HYPOAESTHESIA (My cheeks and teeth felt very numb) had resolved. At the time of the report, VACCINATION SITE INFLAMMATION (Inflamed), VACCINATION SITE SWELLING (Swollen and red where I got shot, closer to my elbow swollen like baseball), VACCINATION SITE ERYTHEMA (Swollen and red where I got shot) and VACCINATION SITE PAIN (Very sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information included ibuprofen.  Concomitant drugs includes Arimidex   Reporter did not allow further contact
Mild prickly sensations on the back of  hands.; burns to wash my hands; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6206) in the arm right on 11Mar2021 at 10:30(at the age of 52-year-old)  and the patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EP7533) in the arm right on 31Mar2021 at 13:30(at the age of 52-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. 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. The patient did not have allergies to medications, food, or other products. On 18Mar2021, the patient experienced mild prickly sensations on the back of her hands, soon after the booster dose the sensations were more intense and burns to wash hands. The patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcomes of the events mild prickly sensations on the back of  hands and burns to wash hands were not recovered at the time of the report.   No follow-up attempts are needed. No further information is expected.
Individual reported positive Covid result on 12/19/21. She's still symptomatic with multiple symptoms and will continue to remain in isolation until 12/28/21; she will callback for follow up.  4 other family members are positive too and 3 others are waiting for results.
Vaccine vial stored longer post puncture than recommended period of time, potentially stored up to 28 days. No adverse effects, no illness
Patient was supposed to get the COVID bivalent booster vaccine but got the Moderna monovalent vaccine instead.
pt recvd vax & 9 days later exp severe abdo pain & tachycardia; tx surgical exploration of the abdo; p/general anesthesia the heart rate slowed down;
Day 1: Fussiness "Not herself". Day 3: Vomiting and Diarrhea. Day 5: Fever 101.3 - Cold symptoms. Day 7-14 Full blown cold - very fussy- started "banging head",  definately not herself. Hives day 1 and day 2.
C/O pain in both arms and legs, severe headache and fever....crying...gave tylenol and slept for 16 hours
Patient presented to the clinic for a routine establish care appt. on 5/18/18. Patient was given VIS and signed consent for PNEUMOVAX vaccination. Location mapped out with two finger widths below left shoulder. Vaccination given without complaint from patient. Patient called on call provider approximately 4 hours later and stated that she could not move her left arm. Was informed to see PCP. Was seen on 5/21/18 and noted to have slight bruise at injection site and inability to freely move should region of arm. Patient informed that this was a reaction and to allow time. Patient presented to clinic for no relief of symptoms on 5/23/18. Patient continues to complain of pain and inability to freely move shoulder region of left arm.
5NOV91 pt exp local reaction @ the site of flu vax resulting in extreme heat, erythema & induration of the rt deltoid muscle, 15 by 16 cm in size; also inflammation of the site; pt is allergic to PCN;
Seizure on 10/10/09 - 3 minutes. Taken to ER and released that evening. Sent to Dr  at hospital. 1 EEG and 2 MRI's taken on 10/12/09 and 2/2/10.
Patient complained of dizziness at conclusion of 15 min observation, she rested for an additional 15 min and claimed her dizziness resolved
heart palpitation; chest tightness; flu like symptoms; lost 8lbs; fever; has no energy, has only been able to go from bed to couch; This spontaneous case was reported by a physician and describes the occurrence of PALPITATIONS (heart palpitation), CHEST DISCOMFORT (chest tightness), INFLUENZA LIKE ILLNESS (flu like symptoms), WEIGHT DECREASED (lost 8lbs) and PYREXIA (fever) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Apr-2021, the patient experienced PALPITATIONS (heart palpitation), INFLUENZA LIKE ILLNESS (flu like symptoms), WEIGHT DECREASED (lost 8lbs), PYREXIA (fever) and FATIGUE (has no energy, has only been able to go from bed to couch). 16-Apr-2021, the patient experienced CHEST DISCOMFORT (chest tightness). At the time of the report, PALPITATIONS (heart palpitation), CHEST DISCOMFORT (chest tightness), INFLUENZA LIKE ILLNESS (flu like symptoms), WEIGHT DECREASED (lost 8lbs), PYREXIA (fever) and FATIGUE (has no energy, has only been able to go from bed to couch) had not resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: (Negative) negative.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications provided. Treatment included  drinking water and juice, getting at least 12 cups of water a day and taking Tylenol for fever.
A quarter size red circle on skin. Thought it was bug/spider bite. After 2 weeks progressed to pustules looking bumps spreading all over abdomen and breasts. First doctor visit diagnosed bug bites?  Kept spreading, hard to wear clothes. Saw another doctor May 4. Diagnosed plaque psoriasis and put me on prednisone for 12 days. Psoriasis abating now but still have pop ups.
Severe swelling of arm about 2 inches from injection site/ raised skin 3 days after dose; Severe swelling of arm about 2 inches from injection site. Very hot to the touch and purple/red in color; Severe swelling of arm about 2 inches from injection site. Very hot to the touch; This is a spontaneous report from a non-contactable consumer, the patient. A 32-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. Medical history was not reported. 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 COVID-19 vaccine. Concomitant medications were not reported. On an unknown date, the patient experienced severe swelling of arm about 2 inches from injection site. On an unknown date, 3 days after vaccination, the patient experienced very hot to the touch and purple/red in color and raised skin. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events severe swelling of arm about 2 inches from injection site/ raised skin 3 days after dose, very hot to the touch and purple/red in color were unknown at the time of this report.  No follow-up attempts are possible. No further information is expected.
Nothing happened until October 20 when I tested Positive for COVID-19. I was having chills, fever, cough, diarrhea.  I contacted my doctor and he prescribed Paxlovid, I took 10 doses over 5 days (twice a day) starting October 21 and ended today (10/26).
24 hours after second shot I had a sever migraine, nausea, pain in joints/bones, and fatigue.  My lungs also had a minimal amount of pressure/discomfort
FEVER BETWEEN 102.5 AND 103.7 FOR 50 HOURS; DIFFICULT TO CONTROL WITH MOTRIN AND UNRESPONSIVE TO TYLENOL // RASH: PENCIL POINT RED/PINK DOTS ALL OVER FACE&ARMS, SOME ON CHEST&BACK, A FEW ON HANDS, FEET AND LEGS--LASTING MORE THAN 5 DAYS (CURRENT) // EXTREME TIREDNESS LASTING MORE THAN 4 DAYS (CURRENT)
slept following immun until 830PM nursed diaper changed 915PM "pale & limp" observed by mom-lasted approx 3-5 mins then nursed & slept; mom contacted clinic next day pt doing well;
1st immediate was migraine due to stress of not wanting vaccine but my employer requiring it as condition of employment.  Had not had a migraine since the death of my children's father.    -4 hours later had a temp of 100.3F.   4 hours later had fever blisters forming above and below my lips. 12 hours later all mosquito bites on my body turned from dime size bumps to 3 inch hives - began to take benadryl;  12 hours later body aches were beginning - began to take ibuprofen 12 hours later a stiff neck was starting 24 hours later the diarhea started. = started imodium 24 hours later blisters began forming inside my nose  48 hours later - just starting to feel better.  Still taking  benadryl, ibuprofen and imodium
My son complained headache @ 12pm and it went away after eating lunch, then 6:30pm he was experiencing a severe headache, lying and feeling nausea. I called Dr. who gave him the vaccine yesterday and asked for his advise. I gave him Tylenol to reduce the headache.  @7:00PM he vomited a lot and fell asleep right after that.  He woke up @9:40pm and said headache got reduced yet still exist.
No adverse event; They have more or less 192 patients who had been administered with the Moderna vaccine (more or less 170 -monovalent and 20 bivalent) which were beyond the 30day beyond use date.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (They have more or less 192 patients who had been administered with the Moderna vaccine (more or less 170 -monovalent and 20 bivalent) which were beyond the 30day beyond use date.) and NO ADVERSE EVENT (No adverse event) in a 58-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939902) for COVID-19 prophylaxis.     No Medical History information was reported.    On 29-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (They have more or less 192 patients who had been administered with the Moderna vaccine (more or less 170 -monovalent and 20 bivalent) which were beyond the 30day beyond use date.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (They have more or less 192 patients who had been administered with the Moderna vaccine (more or less 170 -monovalent and 20 bivalent) which were beyond the 30day beyond use date.) and NO ADVERSE EVENT (No adverse event) 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 considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (They have more or less 192 patients who had been administered with the Moderna vaccine (more or less 170 -monovalent and 20 bivalent) which were beyond the 30day beyond use date.).    No concomitant medicine were reported. No treatment medicine were reported. lot 042J21A should have been reported with a BUD of 17-Feb-2022.   This case was linked to US-MODERNATX, INC.-MOD-2023-704416 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 24-Jan-2023: Live significant follow up: Updated narrative.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704416:Master case
Redness swelling extreme pain at vaccination site -48 hours following vaccination  Nausea, diarrhea, fever, light headed -48 hours following vaccinations
Had MMR on Thursday, 12/27/01 at about 13:00 and on Sunday, 12/30/01, at about 01:00, noticed redness, swelling of eyelids, burning and itching of face, chest at trunk. Took Benadryl and got no relief. Called the health dept on 12/31/01. Please note: had Measles only vaccine on 7/6/67 and Rubella only on 3/6/90.
All toes are numb all day and night since vaccine one week ago.   I thought it would subside.   I just want to document this reaction.