chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Her menstrual cycle started on Thursday night into Friday night./She doesn't think it caused her cycle. It was due to come. She found she was depleted.; more tired; weaker than usual; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 11Mar2021 11:40 (Lot number: EN6206) at the age of 45 years as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "low hemoglobin" (ongoing), notes: was taking iron in Nov,Dec and Jan. The past few months she went to the emergency room. There were no concomitant medications. The following information was reported: FATIGUE (non-serious) with onset 11Mar2021, outcome "recovering", described as "more tired"; ASTHENIA (non-serious) with onset 11Mar2021, outcome "recovering", described as "weaker than usual"; MENSTRUAL DISORDER (non-serious), outcome "unknown", described as "Her menstrual cycle started on Thursday night into Friday night./She doesn't think it caused her cycle. It was due to come. She found she was depleted.".  Additional information: Patient was wondering in terms of side effects. Her menstrual cycle started on Thursday night into Friday night. Patient has had a low hemoglobin. It was acute and bears on her period. The past few months she went to the emergency room. It had been an issue for the past few months. She was taking iron in Nov, Dec and Jan. She did not have issues. This past period cycle she has had the issue. This was an ongoing health issue. The vaccine may not have made it worse. She wanted to be sure her condition was improving and having the vaccine at the same time did a number on her body. Patient did not have any prior Vaccinations within 4 weeks.   No follow-up attempts are possible. No further information is expected.
Lt bicep swelling under injection site with redness and hot to touch. Pain when flexing muscle.
Patient complained of difficulty breathing, swelling in throat, difficulty swallowing and difficulty speaking at 2:01pm.  We administered Epinephrine auto-injection 0.3mg 2:02pm, EMS was activated at 2:04pm.  Patient was able to verbalize improvement at 2:05pm.   EMS arrived at 2:10pm, evaluated the patient who was found to be stable.  She refused to be transferred to the ER and was discharged home with family/friends at 3:06pm.
5 minute post injection , c/o lightheaded; was clearly very diaphoretic. Reported she had not eaten anything prior to her arrival. Blood pressure 66/42 pulse 52 spo2 98%.  Orange juice provided and patient drank approximately 240cc and tolerated well. Vitals repeated in 10 minutes BP104/60 spo2 99% and pulse 70.  Continued to improve and returned to baseline within the 30 minute wait period and was released to home with significant other driving.
Patient called our onsite registered nurse on 15MAR21 at 1400 to report muscle pain and pain, redness and swelling at the injection site (left deltoid).
STARTED TO NOTICE A LITTLE BUMP ON HER SHOULDER AND BY THE END OF THE DAY IT WAS THE SIZE OF A QUARTER. REPORTS THAT IT IS WARM, RED AND HURTS WHEN MOVING ARM AROUND OR TOUCHING SHOULDER AREA.
I started getting symptoms of URI symptoms. I did a home test that was negative. The next day I developed adult croup and then I had a positive PCR COVID-19 test. I went to the ER and received high dose steroids. The steroids did help. I am getting an anti-body infusion today.
Redness, swelling, burning/pain, war to the touch, increasing 72 hours after injection.
vomiting; bad chills; shaking; and had a temperature of 99.2 degrees Fahrenheit; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 5-year-old male patient received BNT162b2 (BNT162B2), on 27Jun2022 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation; measles vaccine, mumps vaccine, rubella vaccine (MMR), on 27Jun2022 (Batch/Lot number: unknown) for immunisation; polio vaccine (POLIO), on 27Jun2022 (Batch/Lot number: unknown) for immunisation; varicella zoster vaccine (VARICELLA VACCINE), on 27Jun2022 (Batch/Lot number: unknown) for immunisation; diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (TDAP), on 27Jun2022 (Batch/Lot number: unknown) for immunisation; diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (DTAP), on 27Jun2022 (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PYREXIA (non-serious) with onset 27Jun2022, outcome "unknown", described as "and had a temperature of 99.2 degrees Fahrenheit"; CHILLS (non-serious) with onset 27Jun2022, outcome "unknown", described as "bad chills"; TREMOR (non-serious) with onset 27Jun2022, outcome "unknown", described as "shaking"; VOMITING (non-serious) with onset 27Jun2022, outcome "unknown". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The caller was calling about her 5-year-old son who got his first Pfizer BioNTech Covid-19 vaccine today. 4 hours later he was vomiting, had bad chills, was shaking, and had a temperature of 99.2F. He also got all of his kindergarten shots today too- MMR, polio, varicella (with the MMR), and Tdap. She wanted to know if other kids had this experienced this and how long will it last. Caller was calling about the Pfizer COVID-19 vaccine. The patient, who is 5-years-old, got his first Pfizer COVID-19 vaccine today and was doing okay, the Pfizer COVID-19 vaccine was in patients system for about 4 hours, then patient started vomiting, had bad chills, was shaking, and had a temperature of 99.2 degrees Fahrenheit. Patient also got his kindergarten shots today too, which was MMR, varicella, which they put the varicella with MMR, polio, and the patient also got DTaP. Declined to provide additional reporter details or complete a report, requested to get transferred to hospital.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Have artificial right knee.  Day after shot starting getting pain in knee.  Still have pain today 2/22/2021 2 days after shot.  Don't know if related but have not had pain in this knee for the last 7 years.
On Friday April 16th, 2021, at around 12:10 AM, I had responded to an email for work that I forgot to respond to in the afternoon because I was receiving my first Moderna vaccine at that time. The email induced a lot of stress and shortly thereafter I felt my chest feeling heavy and started wondering whether I had trouble breathing. It is currently Friday April 16th at 1:32 AM, I woke up my housemate and we took a walk around the block for about 30 minutes and I am feeling better. Since receiving the Moderna injection, the area that received the injection has felt sore.
This is a spontaneous report from a contactable physician.   A 66-year-old Caucasian female patient received pneumococcal 13-val conjugate vaccine (dipht crm197 protein) (PREVNAR 13) (Unclear lot number: T08483 or TO8483; Expiry Date 30Sep2019; NDC number 0000519710), intramuscular in right deltoid on 17Oct2017 at 0.5 ml, single for immunisation , and first dose of influenza vaccine (FLUZONE) (Lot UI877AB; Expiry Date 17May2018), on 17Oct2017 intramuscular in left deltoid at unknown dose for immunisation. Medical history included bariatric surgery in Nov2014, ongoing iron deficiency and due to this she probably had a B12 deficiency too, cervical cancer, ongoing gastrooesophageal reflux disease treated with ranitidine. Concomitant medication included ongoing ranitidine (unknown manufacturer) 75 mg twice daily for reflux. On 18Oct2017 the patient experienced pain to right arm from shoulder down to her elbow, and numbness and weakness to third fourth and fifth fingers of right hand. On 26Oct2017 the patient experienced pain across right upper back and shoulder blade area. The events were considered serious as medically significant. The outcome of the events was not recovered. The physician considered the events related to pneumococcal 13-val conjugate vaccine (dipht crm197 protein).; Sender's Comments: Considering the plausible time association, the vaccination with PREVENAR 13 might have played a contributory role in triggering the occurrence of events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Started with headache.  1845 had mild itchiness (pin prick). About 2000 noticed hives on thighs and arms.  2330 Fever 101.8F and mild swelling of eyes/lips.  Self medicated with OTC Tylenol and Benadryl.  Symptoms resolved by end of next day.
Brutal after second dose; She is dizzy; Diarrhea; Her back hurts from the middle down towards her legs; Has palpitations at times she can feel her heart; She fell and was lying on the floor for a while until she managed to get up; Sweating; Vomiting; Headache; High fever; Shivering; This spontaneous case was reported by a patient and describes the occurrence of FEELING ABNORMAL (Brutal after second dose), DIZZINESS (She is dizzy), DIARRHOEA (Diarrhea), BACK PAIN (Her back hurts from the middle down towards her legs) and PALPITATIONS (Has palpitations at times she can feel her heart) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044821A and 040821A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-May-2021, the patient experienced FEELING ABNORMAL (Brutal after second dose), DIZZINESS (She is dizzy), DIARRHOEA (Diarrhea), BACK PAIN (Her back hurts from the middle down towards her legs), PALPITATIONS (Has palpitations at times she can feel her heart), FALL (She fell and was lying on the floor for a while until she managed to get up), HYPERHIDROSIS (Sweating), VOMITING (Vomiting), HEADACHE (Headache), PYREXIA (High fever) and CHILLS (Shivering). At the time of the report, FEELING ABNORMAL (Brutal after second dose), DIZZINESS (She is dizzy), DIARRHOEA (Diarrhea), BACK PAIN (Her back hurts from the middle down towards her legs), PALPITATIONS (Has palpitations at times she can feel her heart), FALL (She fell and was lying on the floor for a while until she managed to get up), HYPERHIDROSIS (Sweating), VOMITING (Vomiting), HEADACHE (Headache), PYREXIA (High fever) and CHILLS (Shivering) outcome was unknown.            No concomitant medications provided.  Treatment information mentioned Tylenol.  The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events was not applicable.   This case was linked to MOD-2021-132469 (Patient Link).
Patient had acute onset of soft tissue swelling in knot like distribution immediately following vaccination administration IM. No complaints of pain, dermatological changes, loss of range of motion.  Patient was monitored for 30 mins at site with application of ice to area without worsening symptoms or progression.
Systemic: Fainting/Unresponsive-Medium, Systemic: Hypotension-Medium, Additional Details: Patient had vasovagal reaction.
We administered a COVID19 bivalent vaccine that was over the BYD. We pulled it from the fridge and first punctured it at 11:10am on 1/9/23. It should have been discarded on 1/9/23 at 11:10pm. We administered the vaccine at 1:50pm on 1/10/23. We have contacted Pfizer on how to proceed.
Nausea; fatigue; fever; pain at injection site; Headache; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (fatigue), PYREXIA (fever), VACCINATION SITE PAIN (pain at injection site), HEADACHE (Headache) and NAUSEA (Nausea) in a 63-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced FATIGUE (fatigue), PYREXIA (fever), VACCINATION SITE PAIN (pain at injection site) and HEADACHE (Headache). On 27-Jan-2021, the patient experienced NAUSEA (Nausea). On 23-Jan-2021, FATIGUE (fatigue) and PYREXIA (fever) had resolved. On 27-Jan-2021, HEADACHE (Headache) had resolved. On 29-Jan-2021, VACCINATION SITE PAIN (pain at injection site) had resolved. At the time of the report, NAUSEA (Nausea) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Mar-2020, Coronavirus test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Fever, chills, myalgias. Began 1/7/21 at 0130 and persisted until 1/7/21 at 2200.
headache, fatigue, injection sight pain, muscle pain, chills, joint pain, feeling unwell, arm pain
This case was reported by a lawyer and described the occurrence of joint pain in a 33 year old female who received lyme disease vaccine recombinant OspA (LYMErix) injection for prophylaxis. A physician or other health care professional has not verified this report. On an unspecified date, the patient received LYMErix. At an unknown time after receiving LYMErix, the pateint experieced "severe joint pain". Time to onset, treatment, and outcome were not reported.
EXTREME PAIN IN RIGHT SHOULDER AREA WHERE IMMUNIZATION WAS ADMINISTERED. DIAGNOSED WITH SIRVA BY NURSE PRACTITIONER. PRESCRIBED STEROID AND NSAID FOR PAIN RELIEF.
No adverse affects reported; improperly stored VARIVAX was administered to patient on 5/18/2020; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not provided.      On 18-MAY-2020, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) (lot # S012036 with expiration date 17-APR-2021; dose, frequency and route were not reported) for prophylaxis (product storage error). No adverse affects were reported.  The temperature excursion was 48.2 (unit not provided) for 4 hours. There was not previous temperature excursion. Data logger was involved.
1130 am Thursday 2/4 shot #2, no effects, less pain than #1 8 pm Thursday increased pain at surgical incision sites from my gallbladder which I was 3 weeks post-surgery, body aches, chills, mild fever, fatigue, sore arm 11pm headache, body aches, dizziness, continued, chills and fever 2am chills gone but sweats, sore throat, extreme fatigue, body aches Fri 2/5 730 am upset stomach, fatigue, loss of appetite, dull sense of taste, mild cough Sat 2/6 still lack of appetite, cough, runny nose, diarrhea, until 6p, then appetite suddenly recovered, fatigue improved but severe headache started back at 10p w/dizziness Sun 2/7 mild cough, mild headache, headache treated with Advil and subsided but came back, some dizziness after snow blowing a couple inches of snow. Mon 2/8 down to just fatigue, first day feeling back normal
I felt feverish/had chills and achy all night. In the morning, I also felt very weak, and had to lie down for most of the morning. In the afternoon, I still had chills and sometimes mild fever feeling, but starting regaining my strength. Felt better in the evening, and by the next morning, I felt fine.
COVID 19; COVID 19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Feb2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 34 years for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "PCOS" (unspecified if ongoing); "obesity" (unspecified if ongoing); "non alcohol fatty liver" (unspecified if ongoing). Concomitant medication(s) included: VITAMIN D3. Past drug history included: Clindamycin, reaction(s): "allergies". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: in Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient received Paxlovid as covid-19 treatment on 12Aug2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
5 days after vaccines given - developed high fevers x 3-4 days, severe headache, cervical lymphadenopathy. Eventually put on AUGMENTIN empiric treatment & improved within 36 hrs.
Starting 10 hours after vaccine I experienced rigors, fever to 103 lasting 12 Hours, Then fever to 100.7 lasting an additional 24 hours, one episode of vomiting, severe headache, body aches and fatigue lasting  48 hours, tho only first 24 hours were severe.  I also have painful swollen axillary lymph nodes on that side three days later. My arm is only moderately sore. I did many arm circles the day of the vaccine, which may have helped, because arm soreness was much worse after dose 1.
About 30 seconds after receiving my injection I started to feel dizzy, nauseous, blurry vision and a few minutes later my lips and fingertips became tingly and numb.  My cousin let an attendant know and they sent a Paramedic over to our vehicle.  The Paramedic took my vitals (which I believe were all normal) and gave me a bag in case I needed to vomit.  I started to feel a little better about 20 minutes after the injection and chose to go home and rest rather than go to the hospital.  The 2nd day my arm hurt where to injection was given, I had a headache and was still a bit nauseous although I never did vomit.  I still did not feel 100% on the 3rd and 4th day and better on the 5th day.
Right arm with 7 x 6 cm erythema with warmth (right arm only). No other complaints. Probable reaction at DTaP location.
Sore arm; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the right arm on 19Apr2021 at 15:00 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. Patient had no medical history. The patient had no known allergies to medications, food, or other products (reported as NKA). Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not take any concomitant medications within 2 weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. On 19Apr2021 at 18:00, the patient experienced sore arm. Therapeutic measures were not taken as a result of the event. The event did not result in doctor 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 event sore arm was resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
ALL joints severe pain, very achey all over, horrible headache, 2 fingers on r hand would not bend, swollen very itchy injection site, nausea, stiff neck. Started Saturday evening (after injection on wednesday) thru following Monday (time of reporting)
died from Covid; died from Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (death), SUSPECTED COVID-19 (death), outcome "fatal" and all described as "died from Covid". The patient date of death was unknown. The reported cause of death was suspected covid-19, drug ineffective. The consumer reported that she knew 3 people that have died from Covid, 1 wasn't vaccinated but 2 were.   The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101758340 same reporter/drug/ AE, different patients;US-PFIZER INC-202101760616 same reporter/drug/ AE, different patients; Reported Cause(s) of Death: died from Covid; died from Covid
Metallic taste in mouth, hot lips and cheeks, that eve, chills, muscle, arm pain that went into fever increasing to 103.9, deep bone pain,  neck, back, rib pain, chills, severe weakness, decreased mobility, The next day same with a headache and  injection site red and hot size of  3 silver dollars. Day 3  weak, fatigue, aches , back, neck pain, arm pain and hot still huge, low grade fever Day 4  achy, cough, congestion, pain
Immediately S/P vaccine pt experienced diarrhea for 7 days.  1.3 wks post vaccine pt began experiencing HA with tachycardia (120bbm) at 1.5 wks pt began experiencing swelling in the face and neck which worsened around the lips ending in fever blister.  She has lymphadenopathy anterior cervical.
Information has been received from a health professional concerning an 8-week-old male with no pre-existing allergies, birth defects, or medical conditions who on 27-FEB-2007 and 22-APR-2007 was vaccinated PO with the first and second doses of ROTATEQ (Lot # 656188/1238F and Lot # 656383/0235U, respectively). Concomitant therapy on 27-FEB-2007 and 22-APR-2007 included doses of PREVNAR (Lot # B08684C and Lot # B08670H, respectively) administered IM, doses of PEDIARIX (Lot # AC21B92AA and Lot # AC21B114CA, respectively) administered IM, and doses of ACTHIB (Lot # UF073AA and Lot # UF974AA) administered IM. On 27-FEB-2007, after the first vaccination, the patient experienced 2-3 liquid stools for 2 weeks. No blood was noted. Subsequently, the patient recovered. On 22-APR-2007, after the second vaccination, the patient experienced 2-3 liquid stools for 2 days. No blood was noted. Subsequently, the patient recovered. The mother refused the third dose of ROTATEQ on 03-JUL-2007. There were no events following prior vaccinations of the patient or his siblings. Additional information has been requested.