chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient presented with a mild rash around the site of injection on the left arm.  She said that it itched.  I recommended that she take Benadryl by mouth for the itching and to control the reaction and topical Hydrocortisone for itching as well.  I told the patient to keep an eye on it, if the reaction does not resolve in the next 3 days to let me know.
Left arm swollen, warm and mildly tender to palpation. According to mother signs and symptoms revealed themselves 24 hrs after administration of vaccine.
10 days after the vaccine my menstrual cycle started 2 weeks earlier than expected.  I am always regular and this has never happened before to me,  Then, my regular cycle started again 2 weeks after.  So I basically had 2 menstrual cycles in one month.
Patient reported a rash on right side of face from the neck down to shoulder. Tricep and elbow swelling.
PATIENT'S HUSBAND CAME TO PHARMACY AND SAID THE SHOT WAS GIVEN IN BURSA OF SHOULDER, ONLY ONE FINGER DOWN FROM SHOULDER INSTEAD FOR 3 FINGERS DOWN. HE SAID SHE HAD BEEN IN PAIN SINCE THE SHOT AND WANTED RELIEF FROM THE PAIN. SHE IS NURSE AND SAID HER RESEARCH RECOMMENDED A STEROID SHOT. SHE IS GOING TO DOCTOR FOR STEROID SHOT TODAY.
Mom calls on Friday, reports left deltoid red and swollen, took to UC Thursday night given BENARDRYL. No increased swelling but c/o itchiness, not painful.
46yo female is here with 3 weeks of pink rash on her face that yesterday became, painful, burning and itchy; worst at her cheeks.  She had a similar rash on the front of both of her thighs a week ago, which has improved.  No difficulty breathing.  No mouth, throat or tongue swelling.  She received the Moderna Covid???????-19 vax here; the first dose a little over one month ago and the 2nd dose 3 days ago.  No new face products, hair products, soaps or laundry detergent.  No new fabric masks.  No new OTC medications.  She has never had an allergic reaction to a medication, food or sting before.
Information regarding PREVNAR 13 was received from a healthcare professional regarding a patient who experienced injection site pain, excessive redness and excessive swelling. The patient received a dose on an unspecified date. MEDICAL HISTORY: Relevant medical history was not provided. PRODUCT DETAILS: Indication for PREVNAR 13 was not provided. Product was administered on an unspecified date. Dose regimen was 1 dose. CONCOMITANT THERAPY: Concomitant medications were not reported. EVENT DETAILS: The patient experienced injection site pain, excessive redness and excessive swelling. Outcome was unknown. No additional information was available at the time of this report. MANUFACTURER'S COMMENT: The reporter was unable to specify the number of patients who experienced this event. Additional reports will be generated when identifying information is provided.
Soreness in L arm started within two hours. At 6 hours post vaccination, lethargy began. That night, I slept about 12 hours, something I only do when I'm sick. That whole day I had full body aches, was extremely tired, and may have had a low-grade fever in the evening (I do not have a thermometer to verify).
afib and tachycardia for 3-4 days; afib and tachycardia for 3-4 days; chills; lethargy; kind a brain fog; felt like I had a cold spent 2 days feeling like that; She has as temperamental immune system. She is extremely sensitive. She reacts to everything; This is a spontaneous report from a contactable consumer (patient) via Medical Information.   A 72-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose at the age of 72-year-old for COVID-19 immunisation.   The patient medical history included temperamental immune system (she is extremely sensitive. She reacts to everything). The concomitant medications were not reported.  on an unspecified the patient experienced atrial fibrillation (AFIB), tachycardia, chills, lethargy, brain fog, felt like i had a cold spent 2 days feeling like that, hypersensitivity. Therapeutic measures were taken as a result of AFIB, tachycardia. The  outcome of events was unknown.   The course of events was as follows: On an unspecified she had reacted to the first vaccine: the first day she was fine. The next day she had chills, lethargy, kind a brain fog, felt like she had a cold and spent 2 days feeling like that. On Day 3 she had AFIB and tachycardia for 3-4 days saw the heart doctor and got medicine for that. She had a temperamental immune system. The stress test was super important. She was wandering if she had the Pfizer vaccine a week after the stress test. She got it at the university, and she wandered if they were restricted to give it to her a few days after my scheduled date: They wanted to rule out blockage in her heart.  She was having a test done around the same time as the 2nd Pfizer vaccine. She wanted to know if she could get the 2nd dose of the Pfizer vaccine later/ a week after the stress test. She wanted the vaccine, it was important. On 04May21 she was going to have a dye based test checking your heart, a stress test. The stress test was scheduled the same morning as her 2nd dose of the Pfizer COVID vaccine. She was advised to consult with your doctor or pharmacist for further guidance.
This spontaneous report as received from a nurse refers to 2 patients of unknown age and gender. No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported. On 20-JUL-2016, the patients were vaccinated with improperly stored ROTATEQ lot # L035510 with expiry date: 13-MAY-2017 (dosing details were not reported). It was reported that the vaccines were exposed to the temperature of 0.0 C during a time frame of 13 hours and 45 minutes. There was no previous temperature excursion. No adverse were reported. This is one of several reports received from the same reporter. Additional information has been requested.
When I woke up the morning after I receive the vaccine, it was very painful to move my left arm. The pain increased if I moved my arm greater than perpendicular to my body. The worst pain though with with my back. I could not stand up straight without a sharp pain starting in my lower back. I was also extremely tired. So I called into work took some Tylenol and went back to bed. By 1 o?clock that afternoon I had felt fine as if nothing had ever happened.
Breakthrough case admission after 2 vaccines  Pfizer 3/23/21 Lot# ER8727;  Pfizer 4/13/21 Lot# Er8732
After getting the Pfizer-BioNTech first shot my sense of smell and taste changed when it was normal before. It has not returned to normal since and is still different. It changed on 02/05/2021. Coke, Sprite, Pepsi, Mountain Dew, sour cream, ranch, mouth wash and numerous other things taste different while some things taste the same. My sense of smell changed to where my regular cologne smells weird now.
Patient noticed itching to area of vaccine that day 9/26/14, area sore and red. On 9/27/14 area swollen and not able to raise her right arm above her shoulder, not able to fall asleep so took a Aleve help her. On 9/28/14 she noticed that she was short of breath, went away. Her mother told her to come in here to report what happened and she did today 10/2/14.
Hotness in face and flushing, did not feel good, per patient report. Occurred within minutes of shot. 9:05 shot given, 9:08 hotness and flushing feeling. Told patient to sit down. 9:09 Blood pressure reading was 150/90 and pulse 68. Offered a wet/cool compress and patient refused. 9:22-  pt reported feeling better, and left pharmacy.
This spontaneous report as received from a 86 year old male patient with penicillin allergy refers to himself. The patient's medical history included hives. Three years ago (exact date unspecified0 the patient was vaccinated with ZOSTAVAX for Shingles Vaccination. Concomitant therapies included levothyroxine sodium (dosage and manufacturer unspecified) and simvastatin (dosage and manufacturer unspecified). On 16 SEP-2013 the patient experienced shingles. The patient sought medical attention and Aciclovir (dosage and manufacturer unspecified) was given for treatment. None lab diagnostic was performed. The outcome of developed shingles was reported as not recovered/not resolved. Additional information has been requested.
On 10/4 around 1200, i began to experience palpitations, not associated with chest pain, SOB, or dizziness.  My heart rate ranged from 150-190 bpm.  It would slow down and then return to the rapid rate.  Around 1400, the palpitations began and lasted for an hour and a half.   Carotid sinus massage and the Valsalva Maneuver did not work.  Around 1545, I went to UC.  While waiting to be seen, my heart rate began to slow down.  When I was seen, it was 90-100, NSR.  Since my EKG and U/A were normal, I was told to f/u with my PCP.  Saw her on 10/7, AR 65,NSR.  Holter monitor and labs ordered
Vaccine given at 10:00AM  Around 6:00 pm :  super cold  Around 9:00pm: super cold and achy From 10:00pm-1:00pm the next day: heart racing, difficulty breathing and could only say 2-3 words with one breath, very dizzy, super cold, headache, weak, exhausted, felt like I would pass out, vomited once, diarrhea a few times.
Got PCV 20 vaccine on 6/6/22 Didn't hurt at time of shot Hurt later that night Then started to really hurt and get swollen and hot Yesterday was the worst, was crying Today somewhat better Skin: Right upper arm with warmth, mild erythema, palpable thickening approximately 5.5cm x 5 cm, with central area very tender to palpation, no fluctuance Axillae: Right side with prominent lymphadenopathy, tender to palpation; Left without lymphadenopathy, non tender
Sore arm for 4 days, so severe first night that I couldn't sleep. 36 hours after vaccine: nausea, fatigue, fever, headache. To the point where I couldn't get out of bed for 24 hours. Note: I've never had a vaccine reaction before.
Rash day 1-3 mild arm soreness;day 4 she is reporting hives to injection site area and swollen lymph nodes to right neck.  Narrative: reports on day 1-3 mild arm soreness. On day 4 she is reporting hives to injection site area and swollen lymph nodes to right neck.
Involuntary shaking from 12:10 to 1:30 vomiting from 12:10-1:30 only stopped after I took Benadryl. But my body is still recovering from the shaking and vomiting and I am sore all over.
This spontaneous report as received from a pharmacist refers to unspecified number of patients of unknown age and unknown gender. Patients concurrent conditions and relevant medical history was not reported. On an unknown date, unspecified number of patients were vaccinated with improperly stored doses of VAQTA (lot number, dose, frequency and route unspecified) (incorrect product storage). Concomitant medications were not reported. No adverse effects (no adverse event) were reported. The outcome of the events was unknown. The causality of the events with VAQTA was not reported. Product quality issue was not involved. This is one of the several reports from the same reporter. Additional information has been requested.
Had been seen in clinic for ear infection and had been given medicine in a timely manner by parent. Child developed sores in mouth and would not take anything by mouth. On 8/27/00, came to ER and was admitted for dehydration, viral syndrome and sores in mouth. Nystatin relieved mouth sores. Was discharged on 8/28/00 after rehydrated. FNP said she did not think episode was a reaction to vaccine and could receive vaccine in the future.
This case was reported by a nurse and described the occurrence of injection site pain in a 48-year-old female patient who received FLULAVAL QUADRIVALENT (batch number 9X3L3, expiry date 30th June 2015). Previously administered products included flu vaccine with an associated reaction of no reaction to previous exposure to drug. On 15th October 2014, the patient received FLULAVAL QUADRIVALENT. On 15th October 2014, 0 min after receiving FLULAVAL QUADRIVALENT, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was not recovered/not resolved. It was unknown if the reporter considered the injection site pain to be related to FLULAVAL QUADRIVALENT. Additional information received: Nurse reported that a patient complained about pain in her arm and where she received the vaccine.
terrible vertigo; This is a spontaneous report from a contactable consumer. A non-pregnant female patient of unspecified age received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 26Feb2021 as a single dose for COVID-19 immunisation. Medical history included symptoms of having COVID-19, including muscle tremors, chills without (w/o) fever, joint pain and cough from an unspecified date in Feb2021 and unknown if ongoing. It was unknown if the patient had known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. It was unknown if the patient had received other medications in two weeks. On 26Feb2021, the patient experienced terrible vertigo. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event terrible vertigo was recovered on 01Mar2021, after the duration of 72 hours.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Severe worsening of tinnitus. It is much louder than it has ever been.
Sore Arm; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore Arm) and NAUSEA (Nausea) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, the patient experienced PAIN IN EXTREMITY (Sore Arm) and NAUSEA (Nausea). At the time of the report, PAIN IN EXTREMITY (Sore Arm) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medication information provided.
Redness, swelling, warmth and tenderness of L upper arm extending all the way to lower arm, not quite to wrist.
10 days after the second vaccine I developed a low grade fever, congestion, and a enlarged lymph node at the top of my neck. Additionally, my voice was horse and I experienced muscle aches and chills. These symptoms lasted approximately 7 days. I no longer feel sick; however,  the lymph node in my upper neck remains swollen and is hard to the touch.
symptoms started 1/23/2021 Hard Chills, temp spike 103, nausea, frontal headache, and muscular aches, recurrent chills and fever, most of my difficulty came after midnight, I'm not sure exactly when I went to the Dr  maybe 6 days later and admitted me to the hospital, I was fine until two weeks ago I had chills fever and a little nausea and abdominal pain, lab results largely returned to normal and showed the same problem, liver enzymes, 785 amylase. My physician did not want me to get second dose.
BREAKTHROUGH COVID INFECTION. TESTED POSITIVE ON 09/02/2021. PATIENT FULLY VACCINATED ON 03/11/2021.
i started to feel feverish and sick that evening.  I was unable to get out of bed for more than going to the bathroom for about 36 hours  I was unable to go to work.  Nauseated - still having issues with that, got bad enough I needed an IV at home due to lack of food or fluids.  low grade fever for 2 days 99 ish. Tylenol for it.  All over body aches for the 2 days after.  Slept close to 16 hours the next day.  Shoulder rash and pain for 2 days - had to use a ice pack even when sleeping to deal with the pain
My chest hurt, thought it would go away but it didn't so I went to see a doctor finally and was diagnosed with heartburn.
Temporary inflammation in left and right arms. Intense nerve pain sensation in left and right arm. Injection sight inflammation. Changes in skin texture all over neck. Small bumps and a pink discoloration on neck. Strange tickling sensation in heart and feelings of occasional off beat rhythm. Sensation in heart not yet resolved. Pain in both arms resolved in 12 hours. Skin reaction resolved in 3 days.
This spontaneous report was received from a nurse refers to a patient of unknown age. No concurrent conditions and medical history were reported. On 21-SEP-2015 the patient was vaccinated with an expired dose of RECOMBIVAX HB 2.5/0.5 (lot # J001836, Expiry date 01-FEB-2015) 0.5 ml, intramuscularly (dosing regimen and frequency unknown). No concomitant medications were reported. A product quality issue was reported. No adverse effects were reported. The action taken with the therapy with RECOMBIVAX HB was unknown. The outcome of the events was unknown. The relatedness of the events to the therapy with RECOMBIVAX HB was unknown. Additional information has been requested.
Patient felt like she got a cold; Left arm felt a bit warm; Patient felt tired; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (Patient felt like she got a cold), FEELING HOT (Left arm felt a bit warm) and FATIGUE (Patient felt tired) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041C21A, 002C21A and 056H21A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-May-2021, the patient experienced NASOPHARYNGITIS (Patient felt like she got a cold), FEELING HOT (Left arm felt a bit warm) and FATIGUE (Patient felt tired). The patient was treated with FEXOFENADINE HYDROCHLORIDE (ALLEGRA [FEXOFENADINE HYDROCHLORIDE]) at an unspecified dose and frequency and CORTISONE (topical) at an unspecified dose and frequency. On 22-May-2021, NASOPHARYNGITIS (Patient felt like she got a cold), FEELING HOT (Left arm felt a bit warm) and FATIGUE (Patient felt tired) had resolved.            No Concomitant medications were reported.   This case was linked to MOD-2022-481401, MOD-2022-481420 (Patient Link).
Patient had Covid in March 2021, got first vaccine dose in June 2021 and second dose in August 2021. She lost her sense of smell and taste when sick with the virus. They returned after her first shot, but now she has lost her smell again right after the second dose.
vial expired on 8-31-21, dose given from vial on 9-1-21, no adverse reactions noted
? Shortness of Breath     onset this morning, sob and dib. patient tested positive for covid approx 2 days . 90% on RA per ems. 02 applied     HPI Patient is a 83y.o. y.o. female who presents to the ED on 01/10/22 complaining of shortness of breath ongoing for the past 3-4 days with associated fever, chills, and productive cough. Pt states that she was dx with COVID about 2 weeks ago. Denies any nausea, vomiting, diarrhea, chest pain, new leg swelling, or urinary complaints. Does complain of some abdominal pain. States that she cannot lie flat due to her shortness of breath. Denies any recent falls or trauma. Pt has been vaccinated against COVID. PMHx: CHF, takes a water pill. There are no other complaints or modifying factors at this time.   Review of Systems CONSTITUTIONAL:  +fever, chills; no fatigue HEAD:  no headache or loss of consciousness. EYES:  no eye pain, redness or discharge. ENMT:  no ear pain, no throat pain; no rhinorrhea or congestion. CARDIAC:  No chest pain, no exercise intolerance, no tachycardia. RESPIRATORY: +cough, shortness of breath; no wheezing or trouble breathing. GI: +abdominal pain; no nausea, vomiting, or diarrhea. GU:  no dysuria, no increased frequency, no hesitancy MS:  no muscle aches, joint pain or injury. NEURO:  no dizziness, no change in vision, no seizure SKIN:  no rashes; no lacerations or abrasions, no bruising.
p/vax c/o numbness/tingling lt upper & lower arm;no redness/swelling ever noted @ site;no hx of drug of any other injury;seen in office 9/30/99 & 10/15/99;
Pts. mom reported rash, redness, and some swelling on upper right arm. Rash does itch. Pt. has not had to go to ER or PMD. No difficulty breathing. Pt. still going to school. Has been putting Benadryl gel on site with cool cloths. Called pt.10/7/10 and reported doing better.
Pt came to ER c/o weakness and fatigue, lack of strength, chest pain, nausea, SOB, fever, chills, and achy.  Onset 1 week prior was recently diagnosed with Covid.
Patient under 6 months of age was administered Fluzone QIV with no reported adverse event; Initial information received on 20-Oct-2022 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a 12 weeks (3 months and 5 days) old female patient who was under 6 months of age and administered INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 20-Oct-2022, the patient received INFLUENZA QUADRIVAL A-B VACCINE  Suspension for injection (Frequency: once) (strength: standard) (dose, expiry date was unknown) (lot no. UT7689KA) via intramuscular route in the right thigh for Immunization.  On 20-OCT-2022 the patient under 6 months of age was administered fluzone qiv with no reported adverse event (Product administered to patient of inappropriate age) (latency: same day).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.   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 the 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.
I been not feeling good  Since I got vaccines the first time; I felt so tired; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (I been not feeling good  Since I got vaccines the first time) and FATIGUE (I felt so tired) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (I been not feeling good  Since I got vaccines the first time) and FATIGUE (I felt so tired). At the time of the report, FEELING ABNORMAL (I been not feeling good  Since I got vaccines the first time) and FATIGUE (I felt so tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported. No treatment information was provided.