chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Chills, fever, headache, nausea, diarrhea, myalgia, palpitations (same side effects were present after the first dose (12/22) except for diarrhea, a rash developed one week after the first vaccine)
Patient developed a generalized papular rash, distributed mailnly on his trunk and both arms.  Papules become more sparsely distributed in the legs and head/neck regions.  The rash is very itchy.  Patient self administered Benadryl 25 mg tablets every 6 hours without relief.  Consult initiated with allergist ASAP and F/U with Dr. should symptoms worsen.
Pt got shot on 8/7 had some slight itching but no other problems. At about 5 pm 8/8 spot itched again woke up in the night site swelled up to egg size rash itchy could hardly move hand. Rash and itching has moved to include head and neck. Arm was painful went to ER 8/8-8/9.
no additional ae; Temperature excursion of VARIVAX; This spontaneous report was received from an other health professional and refers to a 12-month-old patient of unknown gender. The patient's concurrent conditions, medical history, concomitant medications, drugs reactions or allergies were not provided.  On 12-APR-2021, the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) lot # T021826 with expiration date 25-JUN-2022 (dose, strength, route of administration were not provided) for prophylaxis.  The vaccine experienced temperature excursions of -58 Fahrenheit (F) degrees and +5 F degrees (6.3 F) for 6 hours, 0 minutes and 30 seconds, -58 Fahrenheit (F) degrees and +5 F degrees (10.9 F) for 0 hours, 7 minutes and 30 seconds. Digital data logger was involved. There was previous temperature excursions. No additional adverse events reported.
Pt states 1 week after vaccination she developed swelling, redness, a hot feeling, and itchiness over her entire arm.
recurring swollen face and lips, high fever, body aches , joint pain , myalgias, fatigue, weakness, loss of appetite, dizziness, lightheaded,
8/21/21 - Headache, soreness at injection site 8/22/21 - Overall body aches, muscle aches, chills during morning hours. By 1 PM I had a fever of 101 and increasing muscle, joint and body pain. By 7 PM my fever was 102 and began sweating and having chills. I then took one capsule of Vimovo (500mg/20mg). I sweat profusely all night long and had intense pain in both large and small joints as well as leg and back muscles.  8/23/21 - Body and muscle aches in the morning, fever of 99. By 1 PM fever was still 99 but I was beginning to feel better, with less pain. I did not take any more medication as the CDC site said there may be a better immune response without it. By 5 PM my temperature had returned to normal and I had minimal pain.
CEA level increased; This spontaneous case was reported by a consumer and describes the occurrence of CARCINOEMBRYONIC ANTIGEN INCREASED (CEA level increased) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     Concurrent medical conditions included Colon cancer.   On 12-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Apr-2021, the patient experienced CARCINOEMBRYONIC ANTIGEN INCREASED (CEA level increased) (seriousness criterion medically significant). At the time of the report, CARCINOEMBRYONIC ANTIGEN INCREASED (CEA level increased) outcome was unknown.            patient was on concomitant medications they were not reported.  No treatment information was provided  Company comment: Based on current available information and the temporal association between product use and the start date of the event a causal relationship is unlikely.   This case was linked to MODERNATX, INC.-MOD-2021-106630 (E2B Linked Report).; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the event a causal relationship is unlikely. MODERNATX, INC.-MOD-2021-106630:WIFE CASE
Syncope, Flushing/sweating, dizziness; BP 132/76; HR 90, SpO2 99%
This case was reported by a physician via call center representative and described the occurrence of injection site burning in an unspecified number of patients who received BEXSERO. On an unknown date, the patient received BEXSERO at an unknown dose. On an unknown date, immediately after receiving BEXSERO, the patient experienced injection site burning. On an unknown date, the outcome of the injection site burning was unknown. It was unknown if the reporter considered the injection site burning to be related to BEXSERO. Additional details were reported as follows: The age at vaccination of the patients was not reported. The patients who received doses of BEXSERO, experienced burning sensation at injection site during administration. The Vaccine Service Center Inside sales representative reported the information on behalf of the healthcare professional after he hung up. The healthcare professional was no longer on the phone at the time of adverse event report. No further information was reported.
Pt began to experience chest pain at work on 04-16-2003 and drove to the ER where she consulted her cardiac specialist.  She was hospitalized, an EKG and stress test were performed.  No heart inflammation or damage noted, diagnosis was blood clot that traveled to her heart.  She was put on blood thinners and kept for observation for two day.  She was homebound for 8 days after release.  No further complications noted.  Dr. stated that he did not believe smallpox vaccination was the cause nor had any adverse effect to cause this incident.
Urticaria 1 day later likely related to AUGMENTIN. Treatment: BENADRYL.
Vertigo. Headache. Extremities tingling. Vomiting. Diarrhea. Fatigue. Feeling of bodily weakness. Joint pain. Excessive sleeping. General malaise.
Significant headache, significant arm pain (hard to even move arm), significant right armpit pain, significant aches/pain all over mainly lower back and hips, exhaustion, neck pain
J96.00 ACUTE RESPIRATORY FAILURE 2/16/2022 JAUNDICE J96.00 ACUTE RESPIRATORY FAILURE 2/16/2022 UNSPECIFIED ANXIETY DISORDER J96.00 ACUTE RESPIRATORY FAILURE 2/16/2022 DIARRHEA J96.00 ACUTE RESPIRATORY FAILURE 2/16/2022 UNSPECIFIED ANXIETY DISORDER J96.00 ACUTE RESPIRATORY FAILURE 2/16/2022 ELEVATED LIVER FUNCTION TEST
This is a spontaneous report from a contactable physician via a Pfizer sales representative. A 7-month-old male patient of unspecified race/ethnicity received PREVNAR 13 (Lot# S31257, Exp date Jul2018, NDC# 00051971-01), intramuscular, on 21Aug2017, at 0.5 ml single, for immunisation. Relevant medical history was not reported. Concomitant medication included ACTHIB on 21Aug2017 for immunisation. On 21Aug2017 the patient experienced erratic breathing and shaking of both arms. An ambulance was called and the patient was taken to hospital, but was not admitted. The events were recovering.
Body aches, chills, mild fever, extreme muscle soreness.  Fatigued. Injection spot bruised with large red, hard and very sensitive to touch circle around it about 1.5-2 inches wide that is hot to touch. Has been there now for almost 4 days with no signs of easing up yet.
Unable to lift my arm. Unable to dress. Popping and cracking in my shoulder.  Went to chiropractor 1 week later and advised me to contact my dr. Reported it to my drs office. 1 week later made a appt. Sent me to PT. 1st pt appt last week. Return next week. Cannot sleep on my right side. Wakes me up during tge night. Can still feel where the injection went in. Have to use my left hand to pick up my right arm. At drs visit he ordered a xray of right shoulder came back normal.
DISCOMFORT; TIREDNESS; FEELING MILD NAUSEA; HEADACHE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. 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: Unknown) dose was not reported, administered on APR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On APR-2021, the patient experienced discomfort. On APR-2021, the patient experienced tiredness. On APR-2021, the patient experienced feeling mild nausea. On APR-2021, the patient experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from discomfort, tiredness, feeling mild nausea, and headache on APR-2021. This report was non-serious.
Patient's mother called, left message with receptionist stating that child was experiencing redness and swelling at injection site on left arm. Multiple calls to parents unsuccessful when trying to get more details on patient's current status.
Assistance requested at charting. Patient reports lightheadedness nausea and tunnel vision, decreased hearing. Assisted to chair then then wheelchair. no fainting or loss of consciousness. transported to bay 1 medical monitoring pulse oxygen 99%. Pulse 71. Patient went home afterwards.
Patient reported that upon getting their dose this morning that the vaccinator did not plunge the vaccine into their arm and therefore they did not receive.
Rash over chest and upper arms has taken Benadryl with some relief has taken x 1 today.
Post vax, the pt felt tired. She ran some errands and when she got home she began to feel sick. She went to bed and when she woke up she developed a temperature of 102.6. Treated with Tylenol and Motrin.
Fever; Joint pain; Chills; Nausea; Headaches; Tiredness; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date unspecified), via an unspecified route of administration in Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. In Jan2021, the patient experienced fever, joint pain, chills, nausea, headaches, and tiredness. The patient was asking what he can do to alleviate it and if there was a treatment and patient stated that he can't keep waiting and will have to call back. It has taken him half an hour and he can't wait another half an hour. Outcome of events was unknown.  Information about lot/batch number has been requested.
Patient had red, itchy rash on left arm surrounding the spot of her injection.  It was reported to us on 9/21.
Body aches, headache, low grade fever. Lasted about 24 hours. 48 hours later and still experiencing fatigue
Booster; Flu like symptoms; Fever; Chills; Malaise; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (MANUFACTURER UNKNOWN, Dose1), for COVID-19 immunization; Covid-19 vaccine (MANUFACTURER UNKNOWN, Dose 2), for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 2021, outcome "unknown", described as "Booster"; INFLUENZA LIKE ILLNESS (non-serious) with onset 2021, outcome "recovered" (2021), described as "Flu like symptoms"; PYREXIA (non-serious) with onset 2021, outcome "recovered" (2021), described as "Fever"; CHILLS (non-serious) with onset 2021, outcome "recovered" (2021), described as "Chills"; MALAISE (non-serious) with onset 2021, outcome "recovered" (2021), described as "Malaise".  Additional information- I learned from an acquaintance, who was a woman roughly in her 40s or 50s, that she received a third dose of PFE vaccine (booster) in withheld, and after receiving the vaccine experience flu like symptoms, including fever, chills, and malaise. Those symptoms cleared up within 1 day. I do not have additional information. I was not the patient and do not know the patient; I simply met her once. I have no additional information.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Some soreness in the arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Some soreness in the arm) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044A21A and 037B21A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included PREDNISONE for Inflammation, CYCLOBENZAPRINE for Muscle relaxation, TRAMADOL for Pain.   On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Mar-2021, the patient experienced PAIN IN EXTREMITY (Some soreness in the arm). On 16-Mar-2021, PAIN IN EXTREMITY (Some soreness in the arm) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication use was not provided by the reporter.   This case was linked to MOD-2021-086936 (Patient Link).
pt recvd vax;pt reports 4 days p/vax,started having numbness in toes both feet but lt side is worse;seen by different MD;on prednisone & imoran; myasthenia now ruled out;final dx: GBS, ?peripheral neritis;
May be a coincidence, but symptoms began an hour after the 2nd vaccination, and I have no history of sciatica.  An acute sharp pain started in the left hip, radiating down the front of my to the left ankle. The best diagnosis at the moment is sciatica due to Left L5 radiculopathy.    Treatment sought at urgent care facilities, then a specialty sports injury and orthopedic clinic. Treatment in each case was a course of prednisone and methocarbomol, and physical therapy.  Three months in, the pain is reduced, but still prevents a number of common activities, like driving.  Physical therapy continues, and more tests are scheduled.
My period, that has never in over 20 yeas been early, was 11 days early and started the night I got the shot. I was in horrible, doubled over cramps. Extreme lower back pain. Had an immense feeling of nausea and elevated fever for over a week. I am truly terrified to get my second shot
Entire body ache feeling if heat and weakness fatigue. Severe arm pain. Diarrhea
Within a few minutes after the vaccines were administered developed hives on face, torso & all 4 extremities.  BENADRYL given IM & epinephrine.  Transferred to ER via ambulance for observation.  Did well.  No further care required.  Discharged from ER after 4 hours observation.
STEMI - Was taken to the Cath Lab from the ED. S/p stenting of 1st Diag (which was 100% occluded), angioplasty w stenting of mid LAD and mid PDA. ED visit and hospital admission within 6 weeks of receiving the COVID vaccine.
inadvertently administered Fluzone Quadrivalent instead of Prevnar with no AE; inadvertently administered Fluzone Quadrivalent High-Dose vaccine and Fluzone Quadrivalent instead on same day with no AE; Initial information regarding this unsolicited valid non-serious case was received from Pharmacist via The Agency (Reference number- 00422121) and transmitted to Sanofi on 08-Jan-2021.  This case involves a 65 years old female patient who received a dose of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (prefilled syringe, lot UJ565AB, expiration date 30-Jun-2021) via intramuscular route in the left deltoid and then inadvertently received a 0.5ml dose of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (prefilled syringe, lot UJ442AA, expiration 30 June 2021) via intramuscular route in the right deltoid both for prophylactic vaccination (extra dose administered) instead of PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) [PREVENAR] on 08-Jan-2021 (wrong product administered).  The patient's medical history, medical treatments, vaccinations and family history were not provided. Patient received no other concomitant vaccines.   It was a actual medication error due to wrong vaccine administered and extra dose administered (latency-same day).   At the time of reporting, no adverse event was reported.  The reporter stated that she grabbed the Fluzone Quadrivalent prefilled syringe box instead of the Prevnar box because the boxes for the two vaccines look very similar. Prevnar was not administered. Repoert stated that doctor information not available since the vaccines were administered at a retail pharmacy. The reporter had been trying to reach the patient, but not spoken to the patient since the error.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
she is pregnant and just received the FLUZONE QIV; Initial information received on 21-Dec-2021 regarding an unsolicited valid non-serious case from a consumer or non-health care professional via Regulatory Authority (Reference number- 00906858).  This case involves a 19-years-old female patient was pregnant and just received after receiving INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT]  (exposure during pregnancy).  Data regarding this pregnancy were received prospectively.  Patient was exposed to the vaccine at unknown gestation period.  The date of last menstrual period was not reported.  The estimated due date was not reported.  Medical history, medical treatment, concomitant medication, vaccination and family history were not provided.  On 21-Dec-2021, the patient received a total dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (frequency: once, strength: standard, lot number and expiry date: not reported) via intramuscular route in the right deltoid for prophylactic vaccination.  It was the case of vaccine exposure during pregnancy (latency same day). The patient was pregnant after received FLUZONE QUADRIVALENT vaccine.  Additionally, at time of reporting, the outcome of the pregnancy is unknown.  There will be no information available on the batch number for this case.
first shot about 2 months ago; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (first shot about 2 months ago) in a male patient of an unknown age 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (first shot about 2 months ago). At the time of the report, PRODUCT DOSE OMISSION ISSUE (first shot about 2 months ago) had resolved.            No concomitant medication information provided.
Swelling Information has been received from a nurse concerning a patient who on an unspecified date was vaccinated IM in the arm with a dose of pneumococcal 23v polysaccharide vaccine. Concomitant therapy included an unspecified influenza virus vaccine given in the same arm. Subsequently, the patient developed swelling. Medical attention was sought. Subsequently, the patient recovered. No further information is available.
At first, I thought I was depressed because I was very fatigued & confused & I am usually a very active person & it just got worse & worse & I still feel very foggy in my head & very fatigued.
Patient started noticing severe pain in shoulder after administration of shot.  She went to the ER, where they prescribed pain meds.  Pain has resolved now.  ER nurse told her I might have given it too high.  I did recall her deltoid being small and little muscle mass, so this is possible.
Numbness in left foot, traveled up to left leg & knee, other leg, hand and arms; pain like pins and needles poking all over; Tightening between the ball and heel of her left foot; atrophy in feet; Mild headache; Extremely tired; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Numbness in left foot, traveled up to left leg & knee, other leg, hand and arms), PARAESTHESIA (pain like pins and needles poking all over), PAIN IN EXTREMITY (Tightening between the ball and heel of her left foot), ATROPHY (atrophy in feet) and HEADACHE (Mild headache) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016C21A and 016C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History was reported.  Concomitant products included MAGNESIUM for Muscle disorder NOS, NICOTINAMIDE, PYRIDOXINE HYDROCHLORIDE, RIBOFLAVIN, VITAMIN B1 NOS (B COMPLEX [NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RIBOFLAVIN;VITAMIN B1 NOS]) for Nerve injury, MULTIVITAMIN [VITAMINS NOS], RETINOL (VITAMIN-A), ASCORBIC ACID (VITAMIN-C), VITAMIN B NOS, VITAMIN E NOS (VITAMIIN E), ZINC, MILK OF MAGNESIA and VITAMIN D NOS for an unknown indication.   On 08-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Jun-2021, the patient experienced HEADACHE (Mild headache) and FATIGUE (Extremely tired). On an unknown date, the patient experienced HYPOAESTHESIA (Numbness in left foot, traveled up to left leg & knee, other leg, hand and arms), PARAESTHESIA (pain like pins and needles poking all over), PAIN IN EXTREMITY (Tightening between the ball and heel of her left foot) and ATROPHY (atrophy in feet). The patient was treated with ACETYLSALICYLIC ACID (ASPIRINE) at a dose of 100 mg; GABAPENTIN at a dose of 100 mg; MAGNESIUM SULFATE (EPSOM SALT) for Adverse event, at an unspecified dose and frequency and Physical therapy (Exercises on own) for Hypoaesthesia. At the time of the report, HYPOAESTHESIA (Numbness in left foot, traveled up to left leg & knee, other leg, hand and arms), PARAESTHESIA (pain like pins and needles poking all over), ATROPHY (atrophy in feet), HEADACHE (Mild headache) and FATIGUE (Extremely tired) had not resolved and PAIN IN EXTREMITY (Tightening between the ball and heel of her left foot) outcome was unknown.            Most recent FOLLOW-UP information incorporated above includes: On 20-Jul-2021: Added treatment medications Aspirin & Gabapentin and new events. On 02-Aug-2021: Added New event atrophy in feet and concomitant medications On 13-Aug-2021: Significant TCR received. case updated to not recovered/Not resolved
fever, all over rash, inconsolable crying for three days;developmental delays & autism; gastrointestinal problems
POST VACCINTION , PATIENT REPORTED A LARGE IRREGULAR SHAPED ERYTHAMATAUS RAS, ITCH PAPULAR RASH ON UPPER MID CHEST.  ADMINISTRED : DIPHENHYDROMINE 25MG IM FIVE MINUTES LATER PATIENT REPORTS ITCHINESS HAD SUBSIDED.  NO HIVES OBSERVED
A report has been received from a Health Professional concerning a 53 year old, male subject, who had been receiving FLUMIST. FLUMIST started on an unknown date. The nurse practioner reported that a patient over the age of 50 years old received FLUMIST on 16-Oct-2013. Patient had not experienced any symptoms. The outcome of the event of patient over 50 years of age received FLUMIST is unknown. The report was considered to be non-serious.