chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Blood Clots / Left Leg BKA Amputation; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (Blood Clots / Left Leg BKA Amputation) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031A21A and 003A21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetic, Drug allergy (Relafin), Allergy to antibiotic (Vancomycin), Penicillin allergy, Drug allergy (Phenagryn), Iodine allergy (Iodine) and Allergy to antibiotic (Zosyn).   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-May-2021, the patient experienced THROMBOSIS (Blood Clots / Left Leg BKA Amputation) (seriousness criteria hospitalization prolonged and medically significant). The patient was treated with Surgery (Left leg amputation) for Thrombosis. At the time of the report, THROMBOSIS (Blood Clots / Left Leg BKA Amputation) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient had blood clots from groin to toes, five surgeries were done to remove clots but it was unsuccessful. Patient was underwent 6th surgery to amputate left leg below the knee.  No concomitant medications reported. No treatment medications provided.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.  Medical history of diabetes could be a predisposing factor for the event.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.  Medical history of diabetes could be a predisposing factor for the event.
After the second vaccination have/had severe right arm swelling (still icing arm) entire upper arm swollen no redness; hot to touch; Fever; chills; cold sore upper lip; This is a spontaneous report from a contactable other hcp. A 49-year-old female patient received bnt162b2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection, Lot Number: EN6198), dose 2 via an unspecified route of administration, administered in Arm Right on 03Mar2021 as 2ND DOSE, SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. Patient had previously received first dose of vaccine (Lot number: EM9809) in left arm on 10Feb2021 at 12:30. Patient did not receive other vaccine in four weeks of vaccination.Patient has not been tested for COVID, post vaccination. The patient's concomitant medications were not reported. On 03Mar2021, patient experienced severe right arm swelling (still icing arm) entire upper arm swollen no redness, hot to touch, fever, chills the next day lasting 2 days. Also now have a cold sore upper lip after the vaccination. The action taken in response to the event for bnt162b2 was not applicable. Therapeutic measures were taken as a result of after the second vaccination have/had severe right arm swelling (still icing arm) entire upper arm swollen no redness, hot to touch, fever, chills, cold sore upper lip. The outcome of all events was recovering.  No follow-up attempts are possible. No further information is expected.
pt recv vax 19OCT96 & 26DEC96 pt devel fever 101-102, coughing, sinus drainage, fatigue;fatigue & coughing lasted 2wk;pt contacted MD who prescribed cough medicine, ATB & a sulfa med;pt recovered;
pt c/o sore throat, abd pain; tx w/Amoxicillin, Motrin;
Arm was red and warm to touch. Has taken antibiotics since then ( 11/07/05 ) and redness has gone away after two days
Healthy, stoic 11 year old male received vaccines, walked out, within 10 min nauseated, lightheaded, fatigued - unable to return to school. All symptoms cleared in about 3 hours. No previous hx similar. Ate breakfast.
Patient was given a pediatric dose of Hepatitis A for his second dose in the series.  He did not have any adverse reaction to this vaccine.  The incident was caught immediately and discussed with patient.  The office was out of adult Hepatitis A, so patient was instructed that he would be given the adult Hep A, 2nd dose, at his next office visit.
Initial report received on 18 April 2007 from a physician. A 42-year--old male patient, with no concurrent illnesses, and who had no known drug allergies, had received a dose of Tuberculin PPD, (Manufacturer not provided), and a dose of Typhim Vi vaccine on 17 April 2007. The lot numbers, routes and sites of administration were not provided for either vaccines. The following day, the patient contacted the physician by telephone and reported having difficulty breathing. The patient described it as "mild difficulty with deep inspiration." The patient reported no fever or pain at that time. The patient was going to be evaluated in the physician's office, but the evaluation of that visit was not reported. Per the reporter, the patient had received previous doses of both vaccines, but did not report how many other doses had been received. It was not reported whether any adverse events had occurred with those previous vaccinations. At the time of this report, the patient had not recovered.
Post menopausal for 3 years, but had menstral cycle within a week of vaccine.
Passed out when getting immunizations - 7:20 PM - evening hours.  HPV, Hep A, Menactra, Adacel.
Skin hurts chills no fever, symptoms started 11:00 pm 12:00 am
This spontaneous report was received from an other source and refers to a 6 year old male child patient. The patient's pertinent medical history, concurrent conditions, past drugs and drug allergies were not reported. On 10-MAR-2017, the patient was vaccinated with improperly stored PROQUAD (lot # M001150, expiry date: 05-JUL-2017) for prophylaxis. It was reported that, the PROQUAD underwent temperature excursion in February 2017. This is one of the several reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1704USA004376: US-009507513-1704USA005930: US-009507513-1704USA005932:
Per Mom pt. had fever 101-102 the night after the shot. Hive the next day - they lasted for 2-3 days.
consumer reports having a poss sz 1 1/2 hrs p/recvd vax & PCN on 9OCT92; pt was immunized in ER while being treated for infect of wound on elbow; had been drinking alcohol & no sleep for 22 hrs; MRI & EEG nl;
Patient did not receive the second dose of the Moderna COVID-19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Patient did not receive the second dose of the Moderna COVID-19 vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jul-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Patient did not receive the second dose of the Moderna COVID-19 vaccine). On 28-Jul-2021, PRODUCT DOSE OMISSION ISSUE (Patient did not receive the second dose of the Moderna COVID-19 vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided.   Treatment information was not  provided.  The pharmacist wanted to know if the patient can receive a second dose of the Moderna COVID-19 vaccine or if they need to restart the series.   Reporter did not allow further contact
Immediately following the injection there was injection pain at the site and the muscle function was immediately impacted.  For around 36 hours afterward I was unable to raise my left arm above my shoulder.  After that I was able to do so first with pain, pain subsided after around 48 hours.  Beginning 1/8/2021 I had muscle spasms in my lower left abdomen directly to the right of my left hip bone.  The spasms were not painful, but we?re intrusive and constant.  After around 24 hours they subsided and that region became very sore due to the muscles being overworked by the spasms.  On this day I also developed a headache and low grade fever.  The headache is at its worst when I stand up.  6 days after the vaccination I still have a constant minor headache and get pangs and jolts of pain in the top of my head when I stand up and am nearly constantly fatigued.
jaw was hurting; ear was closed; lips were swollen; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN JAW (jaw was hurting), EAR DISCOMFORT (ear was closed) and LIP SWELLING (lips were swollen) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.  On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced PAIN IN JAW (jaw was hurting), EAR DISCOMFORT (ear was closed) and LIP SWELLING (lips were swollen). At the time of the report, PAIN IN JAW (jaw was hurting), EAR DISCOMFORT (ear was closed) and LIP SWELLING (lips were swollen) outcome was unknown. Not Provided   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant medication was not reported.  Treatment medication was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 21-Feb-2021: Telephone contact, email address provided.
Cellulitis on (L) arm injection site of immunizations 8/23/2012 - date of Imm KINRIX (DTaP & IPV) (L) deltoid IM MMR & Varicella (L) upper arm SQ.
Vaccine breakthrough infection; This literature-non-study case was reported in a literature article and describes the occurrence of VACCINE BREAKTHROUGH INFECTION (Vaccine breakthrough infection) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.      No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINE BREAKTHROUGH INFECTION (Vaccine breakthrough infection) (seriousness criterion medically significant). At the time of the report, VACCINE BREAKTHROUGH INFECTION (Vaccine breakthrough infection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered VACCINE BREAKTHROUGH INFECTION (Vaccine breakthrough infection) to be related.    Concomitant and Treatment Medications were not reported.  Company Comment: This Literature non-study case concerns a patient of an unknown age and gender, with no medical history reported, who experienced the unexpected serious event of Vaccine breakthrough infection. The event occurred on an unknown date after receiving a dose of mRNA-1273 Vaccine. At the time of the report the outcome of the events was unknown. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. The patient is one of twelve patients that was reported to have vaccine breakthrough infections in the study. Further information is requested.   This case was linked to MOD-2022-491471, MOD-2022-491472, MOD-2022-491473, MOD-2022-491474, MOD-2022-491379, MOD-2022-491476, MOD-2022-491477, MOD-2022-491478, MOD-2022-491479, MOD-2022-491480, MOD-2022-491481 (Patient Link).; Sender's Comments: This Literature non-study case concerns a patient of an unknown age and gender, with no medical history reported, who experienced the unexpected serious (medically significant) event of Vaccine breakthrough infection. The event occurred on an unknown date after receiving a dose of mRNA-1273 Vaccine. At the time of the report the outcome of the events was unknown. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. The patient is one of twelve patients that was reported to have vaccine breakthrough infections in the study. Further information is requested.
headache, body aches, fatigue, sore throat, headache, fever, nonproductive cough, diarrhea, sinus congestion, starting on 9/5/21
DTAP & IPV (R) deltoid area has hard induration reactive cellulitis. Patient placed on TYLENOL & AUGMENTIN & warm compress.
Pt's right arm swelled up and working it's way down the arm after 2 days of receiving PNEUMOVAX vaccine. Went to see PCP and diagnosed with a staph infection.
she received her first dose of GARDASIL 9 three years ago and she never received her next two doses" .; no adverse effect; This spontaneous report was received from a female consumer of unknown age regarding herself. The patient's pertinent medical history, concurrent condition, concomitant therapy, drug reactions or allergies were not reported. On an unknown date (reported as three years ago), the patient was vaccinated with first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 1 shot (route of administration, lot number and expiration date were not reported) for prophylaxis. The patient never received the next two doses (inappropriate schedule of product administration). No adverse effect reported. There was no product quality complaint associated with this report.
Swollen glands on side shot administered only . Tonsil on side shot administered was swollen, bleeding and piece of flesh were falling off the tonsil. Fever of 102.5 with Tylenol.
They are half blind from how bad they feel; Have been very sick; Lost their balance; Fallen twice hitting their face and head; Have lost 15 pounds; Second dose they received must have been damaged.; Very high fever; A spontaneous report was received from a consumer concerning a 66-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced fever, very sick, fallen twice, lost 15 pounds and they were half blind.    The patient's medical history included blood pressure and diabetes. Products known to have been used by the patient, within two weeks prior to the event, included metformin.     The patient received their first of two planned doses of mRNA-1273 (Batch number: 011M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection on 05 Feb 2021. On the same day, after vaccination, the left arm inflamed and was red and itchy for 3 weeks.  On 05 Mar 2021, on the same day prior to the onset of the symptoms, the patient received their second of two planned doses of mRNA-1273 (Batch number: CA21A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.   On 05 Mar 2021, same day after vaccination, the patient experienced high grade fever, sickness, lost balance, fell twice hitting their face and head. The patient went to emergency room thrice and was given unknown antibiotics. It was reported that the patient lost 15 pounds and half blind (medically significant) from how bad they felt. The patient stated that the second dose it might have been damaged.  Treatment details included unknown antibiotics and other treatments for the event.    Action taken with mRNA-1273 in response to the events was not applicable.   The outcome of the events high grade fever, sickness, lost balance, fell twice hitting their face and head were considered as recovering. The outcome of the events fell twice hitting their face and head and product damaged were considered as recovered. The outcome of the events lost 15 pounds and half blind were considered as unknown.; Reporter's Comments: Based on the current available information which shows a strong temporal association between the use of the mRNA-1273 and the reported events and excluding all other etiology, a causal relationship cannot be excluded. Fever is consistent with the safety profile of the product; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-049386:Crosslinked for Dose 1
knot at injection site; Pain when touched; Fever after second dose; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE MASS (knot at injection site), PAIN (Pain when touched) and PYREXIA (Fever after second dose) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L20A and 012L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Feb-2021, the patient experienced VACCINATION SITE MASS (knot at injection site), PAIN (Pain when touched) and PYREXIA (Fever after second dose). On 11-Feb-2021, PYREXIA (Fever after second dose) had resolved. At the time of the report, VACCINATION SITE MASS (knot at injection site) and PAIN (Pain when touched) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was provided  Treatment medication was not provided by the reporter
This spontaneous report as received from healthcare worker refers to a patient of unspecified demographics. On 24-FEB-2014, the patient was vaccinated with an expired dose of ROTATEQ, Oral liquid (dose and frequency unspecified) (lot number unspecified, expiry date 07-FEB-2014). Concomitant medication was unspecified. No adverse symptoms reported. No product quality complaint involved. No further information provided. Additional information has been requested.
Only got liquid part of vaccine; Only got liquid part of vaccine; This case was reported by a nurse and described the occurrence of inappropriate preparation of medication in a 11-year-old patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On 20th May 2022, the patient received Menveo. On 20th May 2022, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 20-Jun-2022. Reporter's Comments: Nurse reported that the patient received only the liquid component of Menveo. The reporter noticed 1 powder left in the box at the end. The reporter consented to follow up.  Additional Supportive Information: The patient received only the liquid component of Menveo, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The case was linked with US2022088510 and US2022AMR095691 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022088510:Same reporter US-GLAXOSMITHKLINE-US2022AMR095691:Same reporter
The first night after the injection, woke up in pain whenever I rolled over on the arm.  The next day my left arm was sore particularly when I moved it.  The second night it caused extreme pain when I rolled on it and woke me up so many times, I got up and took tylenol.  The next morning it hurt to raise my left arm and the shoulder joint was sore and stiff. The joint clicks when I try to move it.  When i lift the pain radiates down to my elbow.  It is more severe on day 2 than it was day 1  after the vaccine.  I am hoping it isn't worse on day 3.  It is worsening even after taking Tylenol.
Nausea: Throughout evening Vomiting: A few times in a single 5 minute period at night; nausea stopped afterwards
Trembling due to 103 degree fever, vomiting / nausea Lasted 24-48 hours Then really tired. Now 4/7/23 for a couple days
Approximately 2-3 weeks  after the first shot, I began to have pain in my left shoulder.   It was initially stiff feeling and I wasn't able to raise my arm above my head for long period of time.  The month of June the pain began to radiate down to my elbow and the ability to reach / stretch my arm straight, nor hold my arm up.  At this point I did see my Primary and shared my concern.  He stated,  "it's tendonitis" and order a script for physical Therapy.  In essence, blew me off.  As of today, I have pain radiating from the left shoulder at time up the neck and have ear discomfort.  If I stretch my arm out, I'll have pain that would radiate down to my hand.  I can not reach behind my back!  Any movement beyond my side is Painful.
shingles; This is a spontaneous report from a Pfizer-sponsored program COVAX US support from a contactable consumer. A patient of unspecified age and gender received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced shingles on an unspecified date with outcome of unknown. The patient developed shingles 10 days after received CoVax. Was given Antiviral medication, asked if safe to receive second CoVax. Last dose of Antiviral medication will be given 4 days.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
As the 2nd week came I started feeling slightly tired/weak, but going into the 3rd week I felt that my inhaler was filed with pepper spray. On wed going home had bad cough. Then Thursday , left work early, had to go home. On the way there was like a circle of fire going around my heart to include that part of lungs. Had to bed rest till Monday. Dr. at Emergency gave a prescription of Antibiotics and a cough prescription, my son had to pick it up for me. Then a bout a week later I had finished dinner, taking my plate to the kitchen, body/brain completely quit. No time to get dizzy, speak out or say anything. JUST QUIT. My husband said I was in/out for about 10 minutes as he was trying to help me up. Right side of nose/head still has problems.
injection site pain for 2 days, followed by muscle weakness and pain in knees/thighs. Knee was so bad it was hard to walk for almost 2 days. 6 days post-vaccination and 4 days since leg/knee pain/weakness, improving but not resolved.
Information has been received from a physician concerning a 20 year old female with no allergies who on 27-JUN-2008 was vaccinated with a first dose of GARDASIL 0.5ml by intramuscular injection (lot number 657874/0544X) (injection site not reported). Concomitant therapy included hormonal contraceptives (unspecified) and omeprazole (MSD).  On 27-JUN-2008, after the vaccination the patient experienced lightheaded, jittery and sweating. Later on the same day the patient began to experienced nausea which increased in severity over the following two days. The patient also experienced tingling and numbness on the right side of her head which persisted 24 hours. Laboratory tests included head CT, which indicated that probable lipoma in the corpus callosum and brain MRI was normal. Unspecified medical attention was sought. Until the time reporting, the patient was not recovered from the events. Additional information has been requested. Additional information is not expected.  10/14/08 Reviewed OB/GYN medical records of 6/25-8/14/2008. FINAL DX: migraine w/o aura w/right occipital neuralgia Records reveal patient experienced usual state of good health on 6/22 w/breast fibrocystic changes.  RTC for vaccination on 6/25/08 & immediately experienced sweating, dizziness, jitters which recurred appprox every 10-15 min x 1 hour before d/c to home.  RTC 7/2/08 c/o right sided head pain w/tingling & numbness x 24 hours, increasing nausea s/p vaccine on 6/25.  Seen by neuro 8/14/08 for increased HA s/p vaccine.