chrisvoncsefalvay/vaers-outcomes huggingface dataset:
fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever) and CHILLS (chills) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Rheumatoid arthritis. Concomitant products included LEFLUNOMIDE for Rheumatoid arthritis.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (fever) and CHILLS (chills). At the time of the report, PYREXIA (fever) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medications were provided.
Before I received the shot, I was a normal, healthy and very active teenager and an excellent student. After the shot, everything changed. My former gynecologist gave me the shot and when I came back 3 days later to tell her what had happened (I'll explain after this), she denied giving me the shot and basically said that there was nothing she could do to help me. I had a severe allergic reaction a few hours after the first shot. I had severe nausea, severe dizziness, and severe shortness of breath. I also was extremely pale and thought that and felt like I was going to pass out. I was taken to the emergency room by my mother and they determined that it was a severe allergic reaction to the shot and suggested to me not to get the second or third shot, which I never did. The following day, I woke up with severe pain and stiffness throughout my whole body, where it was most severe in my entire neck and my entire back. I had never ever had pain this severe in my life until the day after I got the shot and I believe that they are related. I have had the severe pain ever since. It has completely and negatively affected my entire life. I was no longer able to be active, I gained weight, and my grades dropped dramatically. It has also affected my depression at some points and makes it worse sometimes, when before the medication that I am on, worked all of the time, until I had this severe neck and back pain, which at times, has made my depression worse. I am still having a lot of trouble with all of this horrific pain. It has completely debilitated me and I am at a loss for what to do next, because I have tried almost everything in the book, minus surgery.
ACUTE HIVES FROM HEAD TO TOE OF BODY; This spontaneous report received from a patient concerned a 27 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included permanent lung damage, and allergies to insect. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, and expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 18-APR-2021, the subject experienced acute hives from head to toe of body. Treatment medications (dates unspecified) included: hydrocortisone, and diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from acute hives from head to toe of body. This report was non-serious.
This is a spontaneous report received from a non-contactable consumer reported for himself. This male patient with unspecified age received NT162B2 (COVID-19 VACCINE) on unspecified date at single dose for COVID-19 immunization. Medical history was not reported. Concomitant medications were none. The patient experienced a herpes spot pop out on his lip after the COVID vaccine. The outcome of event was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Patient reported that right after receiving shot she experienced slight fever, chills, generalized weakness for 24 hours. She then experienced redness/rash on upper torso. Patient stated she had similar rash when having allergic reaction to other food/drugs. Patient declined to see her physician.
Lost taste after 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (Lost taste after 2nd dose) in a 53-year-old female patient who received mRNA-1273 for COVID-19 immunisation.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Intramuscular) 1 dosage form. On an unknown date, the patient experienced AGEUSIA (Lost taste after 2nd dose). At the time of the report, AGEUSIA (Lost taste after 2nd dose) outcome was unknown.            No treatment information was provided.  No concomitant medication was provided.
<strong>Moderna</strong> <p>Side Effects Reporting Form</p>; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a patient and describes the occurrence of VACCINATION COMPLICATION (<strong>Moderna</strong> <p>Side Effects Reporting Form</p>) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) 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, the patient experienced VACCINATION COMPLICATION (<strong>Moderna</strong> <p>Side Effects Reporting Form</p>). At the time of the report, VACCINATION COMPLICATION (<strong>Moderna</strong> <p>Side Effects Reporting Form</p>) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication and treatment medications are reported
Patient describes arm sore after shot, red and swollen later that evening. That night ran fever all over and had joint pain in knees only. Called 10-20-05 use cool pack on arm and Motrin routinely all day. 10-21-05 states much improved, continue Motrin. Today better, red arm only.
Sharp stomach pain; Gum bleeding (more than normal).; Minor nose bleed; Exhaustion; This is a spontaneous report from a contactable consumer, the patient. A 27-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the right arm on 05May2021 at 12:15 (at the age of 27-years-old) as a single dose for COVID-19 immunisation. No medical history was reported. Concomitant medications included amfetamine aspartate; amfetamine sulfate; dexamfetamine saccharate; dexamfetamine sulfate (ADDERALL) taken for an unknown indication from an unknown date, escitalopram oxalate (LEXAPRO) taken for an unknown indication from an unknown date and lamotrigine (LAMICTAL) taken for an unknown indication from an unknown date. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the right arm on 07Apr2021 at 13:45 (at the age of 27-years-old) as a single dose for COVID-19 immunisation. 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 COVID-19 vaccination. On 05May2021, the patient experienced a sharp stomach pain which started within 30 minutes of the vaccine and lasted several hours (at the time of this report), minor nose bleed, gum bleeding (more than normal) when brushing teeth and exhaustion. The clinical outcome of the events sharp stomach pain, gum bleeding, minor nose bleed, exhaustion was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
The first dose created no reaction other than a sore arm. The second dose caused fever and night chills as well as sickness the first 24 hours. Previous to the second shot, I had been on a consistent 36 day menstrual cycle.  A week after the second vaccine I began spotting mid cycle. The spotting occurred for two days. When I was supposed to begin my next regular cycle post vaccine (approximately 12 days after the spotting),  I failed to start. I took a pregnancy test three days past the expected start date and confirmed that I am not pregnant. I have not changed any other behavior and would reflect this change in menstruation as a result of the vaccine.
Pt received MENACTRA & Tdap in left arm. Following day developed swelling/redness around injection site.
Fatigue, chills, fever started day after injection. Fatigue continued for 3 days, chills and fever for 2 days.
Breakthrough case admission after 5 vaccines Pfizer 2/10/21 Lot# EL3249;  Pfizer 3/4/2 Lot# EN6202;  Pfizer 10/4/21 Lot# FF2587;  Pfizer 4/12/22 Lot# FJ9943;  Pfizer 10/10/22 Lot# GJ3277
I noticed in middle of night I wasn't sleeping well, my heart rate was high, my resting heart rate was in 130's, I did not feel well I was very fatigued, chills and my heart rate slowed down 24 hours later my heart rate returned to normal. I did take 2 doses of low beta blocker over the course of those few days.
Systemic: Allergic: Itch (specify: facial area, extremeties)-Severe, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Severe, Systemic: Body Aches Generalized-Medium, Systemic: Exhaustion / Lethargy-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Neurological Disorder (diagnosed by MD)-Severe, Systemic: Numbness (specify: facial area, extremities)-Severe, Systemic: Seizure-Severe, Systemic: Tingling (specify: facial area, extemities)-Severe
This was the first PROQUAD Vaccine, but the second MMR and Varicella. He woke up in the morning 7:30am with welts on his face (around cheeks, eyes, ears), arms, legs. Some looked like bug bites others were about 3-5 inches- They were raised welts that felt swollen. There was itchiness around his ankles. Later in the afternoon around 12pm I noticed swelling around his ankles.
Two days after vax, right thigh large area of erythema at site 21/2 x 2 inches, non tender, no fever.
Injection site was red, swollen, warm to touch. Hand was numb from the swelling
Tiredness after getting the first dose of Moderna COVID-19 Vaccine, that went away 2 days aft; This spontaneous case was reported by a physician and describes the occurrence of FATIGUE (Tiredness after getting the first dose of Moderna COVID-19 Vaccine, that went away 2 days aft) 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 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Jan-2021, the patient experienced FATIGUE (Tiredness after getting the first dose of Moderna COVID-19 Vaccine, that went away 2 days aft). On 11-Jan-2021, FATIGUE (Tiredness after getting the first dose of Moderna COVID-19 Vaccine, that went away 2 days aft) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.   No treatment information was provided.; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.
Headache, Myalgia, chills Narrative:  received 2nd dose vaccine 1-8. symptom onset 1-9. missed work on 1-11. now better.
sore arm; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 05Oct2021 (Lot number: 30155BA) at the age of 65 years as dose 1, single for covid-19 immunization. Relevant medical history included: "AFib" (unspecified if ongoing), notes: other medical history AFib, "hyperlipidemia" (unspecified if ongoing), notes: other medical history hyperlipidemia. The patient's concomitant medications were not reported. Past drug history included: Oseltamivir, reaction(s): "known allergies: Oseltamivir", notes: known allergies Oseltamivir. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 06Oct2021, outcome "recovering", described as "sore arm". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pain in extremity.  Additional information: COVID-19 vaccine was administered in Public Health Clinic/Veterans Administration facility. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  No follow-up attempts are possible. No further information is expected.
Patient would not comply with mask requirement, got agitated and unruly and was told to leave. Patient grabbed a drawn up syringe and self administered the vaccine in his left arm and left the store. Exact site location unknown, placement unknown, proper dosage unknown, muscle unknown, patient condition unknown.
I was sick for 3 days. fever, chills, diarrea, fatique. Just felt lousy.
an 11 yr old girl recieved Daptacel by mistake instead of the Adacel; an 11 yr old girl recieved Daptacel by mistake instead of the Adacel; Initial information received on 12-Apr-2019 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 11 years old female patient who was vaccinated with once 0.5 ml DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (lot: 5553K, expiry date: 01-Feb-2021) via intramuscular route in the left arm instead of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (lot number not reported) on an unknown date (reported as today).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MENINGOCOCCAL VACCINE A/C/Y/W CONJ (DIP TOX) (MENACTRA) for Immunisation.  It was an actual medication error due to Inappropriate age at vaccine administration and wrong vaccine administered.  It was unknown if any adverse event occurred.  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.  List of documents held by sender: none.
05/18/2018 Phone call received from HCP with concern for "possible vaccine reaction" from HPV vaccine given on 04/18/2018. Patient has been seen in the office for soreness and lump in area of injection on Lt arm. HCP advised to notify Health Department for any further updates. 05/29/2018 Received voicemail from Dr (Infectious Disease) who reports small hematoma in Lt arm was evaluated and reviewed by radiology and no intervention is needed at this point. Dr. did not feel "was a vaccine reaction".
It was reported that approximately 10 minutes after receiving the second dose of the vaccine,  guest stated that she felt nauseous and as if the room was spinning. She sat down and this seemed to improve the symptoms. EMS was called. They did vital signs which were WNL. Guest then stated that she felt better but still slightly lightheaded. Guest was observed for an additional 15 minutes, for a total of 30.  At that point she comfortable and was able to stand/walk with no  balance concerns. Not on medications, no allergies.
A 12 year old received Flublok and not the prescribed Fluarix, no AE; A 12 year old received Flublok and not the prescribed Fluarix, no AE; Initial information regarding an unsolicited valid non-serious case was received from a Nurse via regulatory authority (Reference number- 00444333) and transmitted to Sanofi on 25-Jan-2021.  This case involves a 12 years old female patient who received 0.5 ml dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot QFAA2037, expiry: 30-Jun-2021) via unknown route in the right deltoid for prophylactic vaccination on 03-Nov-2020, instead of INFLUENZA VACCINE INACT SPLIT 3V (FLUARIX) (Wrong product administered and Product administered to patient of inappropriate age)  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HPV VACCINE VLP RL1 4V (YEAST) (GARDASIL), MENINGOCOCCAL VACCINE A/C/Y/W CONJ (DIP TOX) (MENACTRA) and DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS) for prophylactic vaccination.  The Nurse reported that error was found out two months after administration.  It was a case of an actual medication error due to Inappropriate age at vaccine administration and Wrong vaccine administered (latency same day).  At the time of report, no adverse event was reported.  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.
Bells palsy happening on left side of his face, everything is paralyzed, small pain behind left ear, left eye will not close(drys out), and is still going on with no improvement  Went to ER because they thought it was a stroke .
Extreme exhaustion in muscles, dizziness and faintness, headache and nausea
pt recv vax 23JUL97 & exp flu like sx;pt reported that head felt heavy, had chills & stayed in bed all day, felt weak;25JUL97 felt a little better;pt recovered;
Patient states she had pain at the injection site and lasted till now and she feels it radiates from her neck to her arm.
Patient reported:  "The injection site appears to be significantly higher than the recommended location. It appears to be on top of/ in the shoulder area; where you would receive a cortisone injection. She?s now complaining of a ?sharp, cutting sensation? pinpoint to the tip of her shoulder. It is red about the size of a golf ball" Pictures provided appeared to have injection site high and posterior for recommended deltoid injection site. Evaluated by PMD:  "They are unable to tell if the side effects she?s having are from the error in administration site or from the medicine itself. She was advised to follow up in a week and report back if symptoms unchanged or worsening"
Nausea  the next day which persisted with vomiting 48 hours later, nausea resolved Headache, dizziness, fatigue, arthralgia, chills but no fever began approx 16 hours after vaccine and persisted for 4-5 days in "waves" (described by patient) Sore arm for couple days.
Like  I had the flu; Like I was hit by a brick; Terrible headache; Muscular aches and pains; Chills; After receiving the 3rd dose of the vaccine; This spontaneous case was reported by a physician and describes the occurrence of INFLUENZA (Like  I had the flu), FEELING ABNORMAL (Like I was hit by a brick), HEADACHE (Terrible headache), MYALGIA (Muscular aches and pains) and CHILLS (Chills) in a 69-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.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Aug-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXTRA DOSE ADMINISTERED (After receiving the 3rd dose of the vaccine). On 15-Aug-2021, the patient experienced INFLUENZA (Like  I had the flu), FEELING ABNORMAL (Like I was hit by a brick), HEADACHE (Terrible headache), MYALGIA (Muscular aches and pains) and CHILLS (Chills). On 14-Aug-2021, EXTRA DOSE ADMINISTERED (After receiving the 3rd dose of the vaccine) had resolved. On 16-Aug-2021, INFLUENZA (Like  I had the flu), FEELING ABNORMAL (Like I was hit by a brick), HEADACHE (Terrible headache), MYALGIA (Muscular aches and pains) and CHILLS (Chills) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Relevant concomitant medications were not provided.  Patient was not taken any treatment medication.
Muscle pain, headache and hard time focusing on daily activities appeared 7 hours after that shot and didn't go away for nearly 24 hours.  On April 17th, two days after the shot I discovered a large bump (around 4-6 mm) under my skin on my lower neck, on the left side, close to the shoulder. I called a doctor and was advised to observe the bump for a week and schedule an in-person appointment with my doctor if the bump doesn't go away. The doctor said that it's most likely a lymph node.
Myalgia, Fever, Pain to right arm, Lethargy, Chills Narrative:  Other Relevant History:
Information has been received from a physician concerning a female who about 2 wks ago on approx 27Jul06 was vaccinated with a SC dose of MMR. In approx Aug 2006, the pt was admitted into the hospital in septic shock and the pt had encephalitis after receiving MMR + varicella virus vaccine live. The length of hospitalization was unspecified, however, the physician mentioned that the pt was still in the hospital. There was no product quality complaint involved. Septic shock and encephalitis were considered to be immediately life threatening and other important medical events (OMIC). Additional information has been requested.
Pt recvd booster dose of MMR vax on 21OCT91 & 4NOV91 devel t104, Koplik's spots & florid measles; pt tx w/Ibuprofen; no further details were provided;
pt recv vax 13JUN97 &  on 20JUN97 pt presented to MD w/strabismus & was dx w/post viral sixth cranial nerve palsy;pt was seen by an ophthalmologist on 24JUN97;16JUL97 pt recovered from exp;
the injection site on Left deltoid was sore the first few days.  However, on day 6, the site became slightly swollen and tender.  The 7th day, the area is red, warm to touch, and rigid.   The range of motion is normal.  My body temperature is 97.7.