chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Intense myalgia for 8 hours starting about 14 hours after the shot, mild myalgia after that; Very sore arm; This is a spontaneous report from a non-contactable physician, the patient. A 43-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6198) via an unspecified route of administration in the left arm on 01Mar2021 at 07:00 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any concomitant medications. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received benzoin (MANUFACTURER UNKNOWN) and experienced drug allergy. On 01Mar2021 at 12:00, the patient had very sore arm. On 01Mar2021 at 21:00, the patient experienced intense myalgia for 8 hours starting about 14 hours after the shot and mild myalgia after that. No therapeutic measures were taken as a result of the events. The adverse events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events very sore arm and intense myalgia for 8 hours starting about 14 hours after the shot, mild myalgia after that was resolving at the time of this report.   No follow-up attempts are possible. No further information is expected.
Information has been received from a LPN concerning a male patient whose 12 month old sone was vaccinated on 09/25/2000 with a dose of varicella virus vaccine live. It was reported that the time of his son's vaccination, the patient was being treated with Medrol dose pack for an unknown problem. The patient subsequently experienced secondary transmission. About 5 days after his son's vaccination on approximately 10/01/2000, the patient developed a fever of 102F. On 10/04/2000 the patient developed a varicella like rash over his entire body and went to the ER. The ER physician confirmed that it was chicken pox and treated the patient with acyclovir and he was released the same day. It was noted that his son attends daycare and no one there has chickenpox. The patient did not have chickenpox as a child. The nurse reported that the child has not had a rash. The plan as of 10/12/2000 was to send a specimen for PCR analysis. Additional information has been requested.
ELEVATED HEART RATE - NORM 60-75 BPM, WENT UP TO 115 - 120 BPM AND STAYED THERE FOR ABOUT 5 - 6 HOURS; SWELLING OF FACE, LIPS
"Bumps" on legs, then trunk, itchy for 2 days.  LGT increased 100.  About 30 lesions, scalp, legs, trunk-papules, vesicles, scabbed.
Information has been received from a registered nurse concerning a female employee with a history of two prophylactic measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation)vaccinations who tested positive for antibodies against measles and rubella, but no for protection against mumps.  The employee does not have a record of her immunizations.  Follow up information was received from the registered nurse who reported that due to the lack of titer they administered a single dose of mumps virus vaccine live to the employee.  Additional information has been requested.
Within 5 minutes of vaccines, pt felt light headed dizzy and passed out to floor. Mother caught her and states she noticed upper body tremor. Began having headache approximately 15 minutes after administration vital signs stable.
Area where shot was given turned red about an hour after receiving shot. Area is currently still red and is hard when pressed down on
MA inserted needle for Flu vaccine. Child pulled back and had no success of injecting the liquid. Second time she poked child. She was able to get some medication when child pulled back. MOC asked to inject the child with vaccine, she told her she couldn't.
Infant became inconsolable with prolonged crying a few hours after vaccines given. Develped  a fever up to 101 and required a sepsis workup and hospitalization, sepsis and w/u negative.
Information has been received from a nurse concerning a male who on 8/10/01 was vaccinated with a dose of MMR (lot # 638514/0375L) at the age of 12 months. The nurse reported that the patient was later diagnosed with autism. Unspecified medical attention was sought. Additional information received from a registered nurse indicated that the patient had a history of an unspecified reaction to his first DTP vaccination, otherwise he had no medical history of any problems. At approximately 18 months of age, the patient became non-verbal, asocial, and displayed hypotonia and decreased balance. The patient was seen by a geneticist, and all tests performed were normal. The patient had recently been diagnosed with autism. The parents were using equine therapy for the patient. Upon internal review, the patient's autism was considered an Other Medical Event (OMIC). Additional information has been requested.
Info has been received from a physician and a health professional concerning an approximately 30 month old female with no pre-existing allergies, birth defects or medical conditions who on 10/18/02 was vaccinated in the right thigh with a 1st dose of varicella virus vaccine live. There was no illness at the time of vaccination. Subsequently, on 3/21/05, the pt experienced a mild case of breakthrough. She was noted to have scattered lesions on the right axilla, left scapula, right inguinal and right knee. The lesions were pea sized and erythematous, with small vesicles at the center. The outcome was reported as recovered. There was no relevant diagnostic tests or laboratory data. No further info was available. Unspecified medical attention was sought. There was no product quality complaint. No additional info is expected.
Pt recvd 2-1cc injects of Recombivax 28NOV90 & 1JAN91; 29MAY91 recvd Engerix-B; pt "did not develop immunity";
Swelling of deltoid right arm, warmth to touch, non tender, full range of motion.
palpations,  SOB, chest pain, tachycardia that started on 8/15 and got progressively worse.
Had a  sore arm, low grade fever, chills and aches starting the nigh after receiving the vaccine that lasted about 24 hours. Menstrual Period came 2 weeks early 3 days after vaccine (this is extremely out of character for my body, and I was not stressed at the time of receiving the vaccine).
Moderna COVID?19 Vaccine "COVID arm" - very large red blotchy arm on left arm. Painful to the touch. Hard. Swollen. About 3" x 2" at the moment. Appears to be getting larger after 40 hours post injection.
Influenza A virus infection; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (Influenza A virus infection) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Ankylosing spondylitis.    No Medical History information was reported.   On 30-Jul-2021, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. 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 23-Aug-2021, the patient experienced INFLUENZA (Influenza A virus infection). In September 2021, INFLUENZA (Influenza A virus infection) had resolved.            No concomitant medications were reported. It was unknown whether patient was enrolled in a COVID-19 Vaccine Trial. The Humira drug was available as Solution for injection in pre-filled pen. The reporter causality for the event of Influenza A virus infection was assessed as "Not reported" for cosuspect humira. 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.   This case was linked to MOD-2021-623880 (Patient Link).   Reporter did not allow further contact
Local area of erythema and induration 5cm x 6cm topical Hydrocortisone cream to left arm
Initial information received on 21-Mar-2019 regarding an unsolicited valid non-serious case received from a physician. This case involves Adult patient who experienced allergy to tetanus, while he/she received vaccine TETANUS TOXOID. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect TETANUS TOXOID produced by unknown manufacturer lot number not reported via unknown route in unknown administration site. On an unknown date, the patient developed a non-serious allergy to tetanus (Unknown latency) following the administration of TETANUS TOXOID. Other relevant tests were not reported. Final diagnosis was allergy to tetanus. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for allergy to tetanus. List of documents held by sender: none.
Continued side effects (12 days after injection) include:  Tremors/Severe Shakes along with Chills occurring at least twice a day earlier and at night now.   The shakes cause my arms/hands to shake hard enough to not be able to hold a piece of paper.  They have occurred with sometimes (the heaviest) three comforters on, plus a heavy robe, warm top and three pairs of socks.  I have started out with lighter clothes and blankets and work up to the warmer wear.  Most chills have woken me up where I have sweated through my clothes.  I have never recorded a fever (e.g. 96 to 97 degrees).  Headache, body aches, nausea, vomit, loss of appetite (e.g. metal after taste in food), diarreha (I ate small dinner and immediately lost it in the toliet today).  I have lost more than ten pounds since my injection.  I have been lightheaded, weak, and very fatigued for days.  In the last three days, I have had a cough and some congestion in my throat.  I have taken sinus medication to address the congestion.  I have also been trying to obtain medical advice as to what to do to resolve some of these issues.  It is scary because the side effects show no end.  I am uncertain if I should take the second shot, if the first dose side effects do not subside or if they are stronger for the second dose.    The duration of the side effects and the degree of severity are of concern to me.
cannot lay on my arm; arm is sore and hurts; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (cannot lay on my arm) and PAIN IN EXTREMITY (arm is sore and hurts) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes and Hypertension. Concomitant products included METFORMIN, GLIMEPIRIDE and DAPAGLIFLOZIN PROPANEDIOL MONOHYDRATE (FARXIGA) for Diabetes, LOSARTAN for Hypertension.    On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Apr-2021, the patient experienced LIMB DISCOMFORT (cannot lay on my arm) and PAIN IN EXTREMITY (arm is sore and hurts). At the time of the report, LIMB DISCOMFORT (cannot lay on my arm) and PAIN IN EXTREMITY (arm is sore and hurts) had not resolved.        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.   It was reported that no medications were taken to help with the symptoms.
Pt got HIGH DOSE flu vaccine NDC: 49281-0397-65 on 8/31, then 9/1 woke up with no grip in hand and wrist pain (on arm where vaccine was administered). Pt advised to seek med attention per Sanofi (manufacturer).
Patient is experiencing general malaise. Patient was advised to take Tylenol or Motrin for pain
no additional AE details; administered after improper storage; Rotateq dose: 0.5 ml; This spontaneous report was received from a medical assistant and refers to a 4-month-old patient of an unknown gender. The patient's medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported.  On 01-FEB-2021, the patient was vaccinated with improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) 0.5 ml (vaccine underdose), lot # 1742461 (valid lot #), expiration date reported and upon internal validation also established as 17-NOV-2021, and improperly stored haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) 0.5 ml, lot # T026959 (valid lot #), expiration date reported and upon internal validation established as 11-MAR-2023 (strength, route of administration and anatomical location were not provided for both products) for prophylaxis. The data logger registered, that the vaccines before administration were stored at the temperature of 9.9 degree Celsius (C) for 35 minutes (improper storage of product in use). No previous temperature excursion detected. No additional adverse event was reported.
PRESENTING PROBLEM: Fatigue, shortness of breath, cough   HOSPITAL COURSE: Patient is an 87-year-old female who was admitted to Hospital on 11/06/2022.  Patient was found to be hypoxic requiring 2 liters of oxygen due to COVID-19 pneumonia.  Patient had 6 days of symptoms she was not started on remdesivir but was started on Decadron.  Today patient weaned to room air with ambulation symptoms are significantly improved.  She still has mucus and cough advise continuing Mucinex otherwise no other medications at this time.   X-ray on admission did show evidence of a mass CT thorax was obtained and showed a hiatal hernia no other concerns, no evidence of PE.   Patient noted dyspnea with exertion longer than the 6 days specifically for 1 month.  Echo was obtained and found normal compared to prior see results below.   We discussed worsening signs and symptoms when to call PCP verses return to ER.  Patient feels stable and ready to go home.  Vitals are all stable medically cleared.
Colonoscopy showed precancerous polyp; Uncontrollable diarrhea; Rheumatoid arthritis pain; Fever after moderna covid vaccine; This spontaneous case was reported by a consumer and describes the occurrence of LARGE INTESTINE POLYP (Colonoscopy showed precancerous polyp), DIARRHOEA (Uncontrollable diarrhea), ARTHRALGIA (Rheumatoid arthritis pain) and PYREXIA (Fever after moderna covid vaccine) in a 61-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) for Rheumatoid arthritis and Ulcerative colitis.    The patient's past medical history included COVID-19 in 2020. Concomitant products included COLESTIPOL HCL and CELECOXIB (CELEBREX) for an unknown indication.   In 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In June 2021, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram every two weeks. In 2021, the patient experienced LARGE INTESTINE POLYP (Colonoscopy showed precancerous polyp), DIARRHOEA (Uncontrollable diarrhea), ARTHRALGIA (Rheumatoid arthritis pain) and PYREXIA (Fever after moderna covid vaccine). In 2021, LARGE INTESTINE POLYP (Colonoscopy showed precancerous polyp) and PYREXIA (Fever after moderna covid vaccine) had resolved. At the time of the report, DIARRHOEA (Uncontrollable diarrhea) was resolving and ARTHRALGIA (Rheumatoid arthritis pain) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Sep-2021, Colonoscopy: Showed precancerous polyp.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment drug information was not provided. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The reporter's causality for the events of COLONOSCOPY SHOWED PRECANCEROUS POLYP, RHEUMATOID ARTHRITIS PAIN, UNCONTROLLABLE DIARRHEA and FEVER AFTER MODERNA COVID VACCINE with HUMIRA 40MG/0.4ML(ADALIMUMAB) was no reasonable possibility. 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.
Pt recvd pneumococcal vax & following vax pt devel an unspecific adverse reaction; No further details were provided;
pounding headache; Chills; This is a spontaneous report from a contactable pharmacist (patient). A 34-year-old female patient received first dose of  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL8982), via an unspecified route of administration in left arm on 19Jan2021 13:45 at single dose for COVID-19 immunization. Medical history was reported as none. Concomitant medication included bifidobacterium lactis (PROBIOTIC), ascorbic acid (VIT C) and a multivitamins. The patient was not pregnant. The facility where the most recent COVID-19 vaccine was administered was in the Public Health Clinic facility. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, it was unknown if the patient was diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 20Jan2021 04:00 AM, the patient stated, "In the middle of the night after my vaccination, I had a pounding headache that is still ongoing as of 11:18 am eastern. I am also now experiencing chills for the last 2 hours (my current body temp is 95 degrees)". The outcome of the events was not recovered. No treatment was given to the patient for the events.
20 minutes post Covid-19 vaccination, pt began to get generalized hives. EMS was called to observation where they administered Diphenhydramine IM to right deltoid. Pt refused further evaluation from EMS and left the facility. Diphenhydramine 25mg IM exp. 08/2022
Day 3 of hospitalization first dose 12/30/2020  100-year-old female sent from nursing home to ED due to AMS x1 day, and elevated creatinine, patient is a poor historian, and history was mainly taken from ED physician/ ED records, apparently, patient was found by nursing home staff, lethargic, sleepy, confused, and disoriented at approximately 9:00 a.m. this morning, with shortness of breath, and occasional cough, with mild sputum production, there has been no, fever, chills, vomiting, diarrhea, patient was in no pain, and in no apparent distress.
Redness and lump on left arm a little warmth. Patient denies pain. Reaction just started yesterday.
Pt came to clinic for PPD test. Mom remarked that the pt's upper arm got swollen and painful after the vaccination.
Mother noticed daughter figit with clothes on back, finally looked, thought dry skin, applied lotion, no help, several hours later, noticed rash, called doctor, examined the following day. Oval salmon colored patches over back were noted, vital signs normal, otherwise unremarkable. Patient instructed to take benadryl and motrin, and to follow up in 5 days, sooner if needed. Followed up in 9 days by phone, rash fading, no other complications noted.
Vaccines given 1/13 and pt presented to ED (on 1/14) with redness/swelling/pruritus to (R) deltoid without fever. Symptoms did not improve and was seen again for additional lip swelling 1/16. Given Rx for ORAPRED/clindamycin. Little improvement and seen again 1/17 for similar.
VOMITING; BAD CHEST PAIN; NAUSEA; BAD HEADACHES; This spontaneous report received from a patient concerned a 37 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A,  expiry: 07-AUG-2021) dose was not reported, administered on 25-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 25-MAY-2021, the subject experienced vomiting. On 25-MAY-2021, the subject experienced bad chest pain. On 25-MAY-2021, the subject experienced nausea. On 25-MAY-2021, the subject experienced bad headaches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from nausea, vomiting, bad headaches, and bad chest pain. This report was non-serious.
A registered dietitian reported that a 27 year old male received injections of Dryvax and anthrax vaccines in 2003 while in overseas. Within hours of receiving the vaccines, he developed severe headaches, chills, and passed out. When he woke up, he was combative. He was hospitalized and diagnosed with bipolar disorder. The pt was subsequently discharged from the duty. No further info was available at the date of this report. The report indicated that her son experienced chills following vaccination with the same vaccines. See related report HQWYE252029JUL03.
pt recvd vax; 28jun95 devel 40 vesicular trunk lesions which were typical of early chicken pox w/ a rose colored base;
pt warned ahead of time they are not good with needles. Patient waited in front of the pharmacy in a chair like they were asked. Witnesses say patient fell out of the chair on his right hand side. I came out of the pharmacy to find him unconscious face down.  I could see he was breathing. I went to get the BP monitor and by the time I go back he was awake. I had him lay on his back with feet elevated. I took his blood pressure (144/78). I brought him a water. He had a red mark on his upper right temple from hitting the floor. He said he had a dull headache but was otherwise fine. I offered him tylenol and he refused.
Site: Bruising at Injection Site-Severe, Site: Pain at Injection Site-Medium
pc from step-mom had rash in AM @ noon felt warm, hives rash on body; will see MD; 320PM f/u call seen by MD given DPH; had worked cattle yesterday poss exposure to eartagn etc;
Patient reported on Monday, Sept. 14th. that she experienced joint pain the evening that she received the injections. The pain continued through the next day. No fever, no treatment. She felt better the next day with no further complaints.
I had started to get short of breath which continue to get worse, went to emergency room doctors treated me with Prednisone intravenous and followed with prescription of prednisone.
Fever low grade, chills, headache, myalgia 1.5 hours after injection. No local reaction noted.
felt crummy; Got chills; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (felt crummy) and CHILLS (Got chills) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042L20A and 030L20A) for COVID-19 vaccination.     Concomitant products included MINERALS NOS, VITAMINS NOS, XANTOFYL (KIRKLAND SIGNATURE ADULT MULTIVITAMIN) from 01-Jan-2020 to an unknown date for an unknown indication.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (felt crummy) and CHILLS (Got chills). At the time of the report, FEELING ABNORMAL (felt crummy) and CHILLS (Got chills) outcome was unknown.            On 10-Jan-2021, patient received concomitant drug Garden of Life Probiotics dose Garden 218 mg, (route-Ingest) 1 capsule per day. On 01-Jan-2021, NeoraFit Block plus Balance Pre and Probiotic dose .07 oz., route: powder, 1 per day before big meal. All reported concomitants were still ongoing.   No treatment drug were reported.  patient was not diagnosed with/ tested positive for COVID-19   This case was linked to MOD-2022-439130, MOD-2022-439598 (Patient Link).
p/vax pt exp painful swollen arm w/red area 2.5'' in diameter; also moderate malaise;MD rpt pt response surprised by react intensity & duration; no tx needed;