chrisvoncsefalvay/vaers-outcomes huggingface dataset:
could barely pick it up; couldn't get warm in bed; left arm is still really sore; got a fever; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION SITE MOVEMENT IMPAIRMENT (could barely pick it up), FEELING OF BODY TEMPERATURE CHANGE (couldn't get warm in bed), LIMB DISCOMFORT (left arm is still really sore) and PYREXIA (got a fever) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Cholesterol (The patient is taking concomitant for cholesterol.).    On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Feb-2021, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (could barely pick it up), FEELING OF BODY TEMPERATURE CHANGE (couldn't get warm in bed), LIMB DISCOMFORT (left arm is still really sore) and PYREXIA (got a fever). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 16-Feb-2021, VACCINATION SITE MOVEMENT IMPAIRMENT (could barely pick it up), FEELING OF BODY TEMPERATURE CHANGE (couldn't get warm in bed) and PYREXIA (got a fever) had resolved. At the time of the report, LIMB DISCOMFORT (left arm is still really sore) outcome was unknown.        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.   Concomitant product include cholesterol medication
This is a spontaneous report from a contactable other healthcare professional (patient). A 24-year-old female patient at same age receive first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9263), intramuscular in left arm on 03Feb2021 12:00 at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced muscular soreness for 24 hours (04Feb2021 12:00), fatigue for 6 hours (03Feb2021 18:00), nausea 12 hours (04Feb2021 00:00) after injection, lasting for 6 hours. The outcomes of events were unknown. The patient was not pregnant at the time of vaccination. The patient was not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19.
Moderna COVID-19 Vaccine EUA  Body aches, tiredness, headache, muscle pain, chills, coughing, injection site pain, exhaustion.
Swelling in face and neck this evening. Starting around 5pm. Shot was a 8:45am. I felt fine most of day except for sore arm. This evening felt tired and swelling started in cheeks, now neck and eyes as well.
Case number PHEH2013US020421, is an initial spontaneous report received from a medical assistant on 27 Sep 2013. This case refers to an 11-years-old male patient. past medical history and concomitant medications were not reported. He was vaccinated with MENVEO, (batch number: not reported), at a dose of 0.5 ml intramuscularly, sometime in Jul 2012. Within 48-hours after vaccination, he experienced redness, swelling and warmth to touch at the injection site. The seriousness, outcome and causality of the events were not reported.
Received afluria pfs 2020-21 inj 0.5 ml; 4 hours later developed chills, fever 102.9, headache. Lasted 24 hours. Day 2 had headache, fatigue, fogginess. Day 3 and Day 7 tested negative COVID.
pt recvd vax 9AM begin crying 1145 screaming for about 1 hr 20 mins; cont to cry until 8PM; temp did not elevate site of inj red & swollen;
Cannot move arm shot injected into; vertigo; every muscle sore; fever; mouth feels like on fire;extreme fatigue
Patient coughing and wheezing. Epi pen  x1 administered and simple face mask at 10 LPM applied and transported to ER.
Patient c/o arm pain in right shoulder. Patient unable to complete range of motion with right arm without severe pain/
Severy body aches, lasted over 2 weeks.  Previously had fibromyalgia, but hadn't had pain like this in a long time. My doctor ended up putting me on a new med Duloxetine for the pain
First round of moderna vaccine received 28days prior when I was not pregnant. After first dose, I had a lard red, indurated but painless bump on my arm for a week. I became pregnant about two weeks after first dose and this, the second dose, was given at four weeks pregnant (due date oct 1 2021). Side effects included fever, chills, muscle aches, very sore arm, light-headedness, tachcardia.
Pfizer 3/23/21, 4/20/21, 11/23/21. Positive on 2/2/23
1 day p/vax pt devel an inj site rxn characterized by soreness & sl redness;the soreness was worse 2 days post vax;this is 1 of 2 reports from this facility of inj site rxn p/vax lot# 4978199
05/11/2022 My Crohn's disease had been doing okay. I started feeling extreme fatigue and was weak. The next day I worked from home because I still did not feel well. I took off on Friday because I was so weak, fatigued, had cramping in my legs, diarrhea. I could not function and slept all weekend. I returned to work that on Monday. I did okay at work until Wednesday and I had another episode of extreme fatigue. This persisted through the weekend. Then I began having stomach cramping and pain, especially upper right abdomen. I could not eat for 3 days. I had loud noises from my stomach. I had an excruciating headache and diarrhea. I laid around in bed for the better part of the day. I had tele health with my GI doctor on May 12 and had blood work done which revealed an iron deficiency and my iron was really high. On May 16 I went to my PCP. She ordered an iron infusion which I had on May 17. The nurse and doctor sent me to an urgent care. They admitted me into the hospital after spending the night in urgent care on 5/18/2022 and discharged on 5/19/2022. They ran more tests, and my albumin was low. At the hospital I received Solumedrol and liquids through an IV. I was diagnosed with Noro virus and was in a Crohn's flair up. I turned around pretty quickly and started feeling better. I am supposed to set up an appointment with my doctor. My stomach is settled where I can actually eat again.
Patient began feeling dizzy and nauseous about 2 minutes after vaccine administration. She couldn?t stand without falling.  911 was called and she was taken to the nearest hospital
Drug ineffective; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 61-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05Mar2021 at 12:30 as dose 1, single (Lot number: EN6198), in left arm and on 23Mar2021 at 14:30 as dose 2, single (Lot number: EN6198) at the age of 59 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Hypothyroidism" (unspecified if ongoing); "Hyperparathyroidism" (unspecified if ongoing); "HTN" (unspecified if ongoing), notes: HTN; "Autoimmune MCTD" (unspecified if ongoing); "Anti-synthetase syndrome" (unspecified if ongoing); "Anti-phospholipid syndrome" (unspecified if ongoing). Concomitant medication(s) included: XELJANZ, start date: 17Aug2022; LEFLUNOMIDE, start date: 13Jan2023; PREDNISONE; BISOPROLOL; SPIRONOLACTONE; LEVOTHYROXINE; VITAMIN D NOS; VITAMIN B12 NOS; IRBESARTAN; MAGNESIUM. Past drug history included: Diphenhydramine, reaction(s): "Allergy"; Statins, reaction(s): "Allergy". The following information was reported: DRUG INEFFECTIVE (medically significant) with onset Feb2023, outcome "unknown"; COVID-19 (medically significant) with onset Feb2023, outcome "unknown", described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical Course: the patient received Paxlovid from 28Feb2023 to 05Mar2023 as treatment for COVID-19.; Sender's Comments: The efficacy of a vaccine varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine product to the reported events drug ineffective and COVID-19 cannot be ruled out.,Linked Report(s) : US-PFIZER INC-202300107499 same patient, different product;US-PFIZER INC-202300108184 same patient and product, different dose and event;
As with all previous covid related vaccinces, I was immobilized -- unable to get up and move around due to:  extreme exhaustion, sore throat, ear congestion/ache, body aches and pains (entire body), rash about the size of two hands at/and/around injection site (at it's peak) and pain; shifting to intense itching - similar to my skin allergic reactions; intermittent chills; night sweats;  this took place over the course of 3 days, now, today 9-29-23 I'm feeling nearly back to normal.  I believe I have recovered.  However, this happening each time I have a Covid vaccine injection is concerning, and I'd like some response from someone about all this.
Patient received vaccine at approximately 1000 was moved to the self monitoring station.  Within 5 minutes of receiving the vaccine patient alerted staff she felt "itchy'.  Clinic removed individual out of self monitoring and brought her to the first aide area for 1:1 monitoring. Vital signs obtained revealed BP of 120/82, HR 86 and RR of 16. Patient denied shortness of breath however clinician noted patient frequently clearing throat. 911 called to dispatch EMS and epi snap kit at bedside however patient declined use of this medication despite education. Patient remained stable until EMS transport. Clinician noted raised red welts appearing on patients back and arms.
gave 0.25 mL to an older adults; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (gave 0.25 mL to an older adults) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7146B) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (gave 0.25 mL to an older adults) and NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (gave 0.25 mL to an older adults) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (gave 0.25 mL to an older adults).    No concomitant medication was reported.  It was reported that they gave 0.5 but initially charted 0.25 and changed it afterwards to 0.5. There was over a milliliter left of vaccine still in the vial after supposedly 5 full doses might have been withdrawn. The vial prior to puncturing was not observed. The vial fill volume was possibly too high. The vial was punctured 5 times. 5 doses were extracted from the vial. The technique was used to load the syringe and puncture technique was used to withdraw the dose was unknown. No treatment medication was reported.  This case was for Adult patient 1.   This case was linked to US-MODERNATX, INC.-MOD-2022-673577, US-MODERNATX, INC.-MOD-2022-673580, US-MODERNATX, INC.-MOD-2022-673578 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 16-Nov-2022: Additional follow-up received QE id was added.; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-673577: US-MODERNATX, INC.-MOD-2022-673580: US-MODERNATX, INC.-MOD-2022-673578:Case for Adult patient 1
The patient developed acute shortness of breath, lethargy, and confusion the morning after the vaccination. EMS was called and she was brought to the emergency department. After evaluation and treatment, she was hospitalized. Hospitalization lasted two days. No other source of the acute symptoms were found besides the recent vaccination.
Had bumps, contacted doctor, doctor stated I had shingles and gave me antiviral.
"feels bruised inside"; swelling on the injection site; hard; itching; This spontaneous case was reported by a consumer and describes the occurrence of CONTUSION ("feels bruised inside"), VACCINATION SITE SWELLING (swelling on the injection site), VACCINATION SITE INDURATION (hard) and VACCINATION SITE PRURITUS (itching) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021, the patient experienced CONTUSION ("feels bruised inside"), VACCINATION SITE SWELLING (swelling on the injection site), VACCINATION SITE INDURATION (hard) and VACCINATION SITE PRURITUS (itching). At the time of the report, CONTUSION ("feels bruised inside"), VACCINATION SITE SWELLING (swelling on the injection site), VACCINATION SITE INDURATION (hard) and VACCINATION SITE PRURITUS (itching) outcome was unknown.            No relevant concomitant medications were reported. No treatment information was provided.
I have a cough, wheezing, shortness of breath, fatigue, headache, fever off and on, nasal and chest congestion, tightness in chest, hypoxic, nasal running They have progressively gotten worse, I've been to ER and to doctor.  I'm now on inhalers, breathing treatments, antibiotics,  steroids. In addition, on the 2and day after my 2and shot, all of my joints hurt so bad it was hard to even roll over in bed. It lasted for 2 days and then didnt come back until last night.  I've been to the ER twice and to the doctor twice and have to go back this week for follow up. Also have swollen lymph nodes from the start in my neck, but now have one near right breast/rib so painful and swollen its hard to move my arm.
Patient said after first dose that his Right Arm became painful and was short of breath - not the typical muscle soreness but it was a noticeable pain that lingered. Lasted about a day in a half and it went away. patient checked with cardiologist and was cleared.
8/16 Per mother, patient had face swelling which started in the morning and improved during the day, but then returned again the next morning (8/17) and worsened throughout the day. Attended school that day and mother reports that face was swollen when she got home.
Urticaria developed 7 days after vaccines treated with BENADRYL & ORAPRED.
Injection site pain lasted 3 days, on the 4th day pt experienced headache which worsened over 2 days and on 3rd day began with painful stiff neck which has lasted for a week, although getting better.  No other injury or illness to account for these symptoms.  Pt was unable to drive for most of the week and did miss some time at work.
I woke up that morning on the 18th and both legs, all muscles were aching really badly. It's a constant ache and it throbs all the time. It's not a shooting or dull pain, it's just an ache of all the muscles from the buttocks to the feet. Even the bottom of feet. Pain is bilateral, it doesn't shift from one side to the other, it's constant pain from both sides. It's been going on from December 18, 2021 all the way up to today. I went to the doctor a week ago and they just said to wait and watch.
Received Tdap injection on 3/28/11. Tuesday noted sx of feeling cold, soreness of arm where injection was received. Temp 102 degrees F. Wednesday returned to work temp 102 degrees F and fell to WNL at noc. Thursday temp 99.4 degrees F and affected arm itchy, warm and swollen.
I received the vaccine on Tuesday, mid-morning, on October 26, 2021. It felt like I was having an inflammatory response by the afternoon. The soreness at the injection site increasingly grew in intensity and the joints throughout my body were radiating pain. I felt awful. I contracted Covid in June of 2021, but this felt worse than the actual symptoms. I self-medicated with 600 mg of Ibuprofen and would alternate with Tylenol. These feelings persisted and by Saturday, October 30, 2021, I started having an upset stomach. I didn't make the connection, and ate lightly the rest of the day. The next day, Sunday, it felt like my entire abdomen was on fire. I tried every home remedy I could think of. Taking Tums, Mylanta, Miralax, and  I went on a liquid diet, but nothing helped. I could not sleep Sunday or Monday night because the pain was so intense. Early Tuesday morning, around 4am, I drove to our local Emergency Room. They gave me IV, administered anti-inflammatory medication, calcium, and performed a CAT scan. The CAT scan revealed the thickening of my colon lining, but no blockages or life threatening issues, so I was discharged. with a prescription for Pepcid. I went to my PCP the next day, and she prescribed Prilosec. When that didn't provide relief, I went back to the hospital on Wednesday and was admitted until Friday, and discharged with gastritis.
patient recieved Fluzone Quadrivalent High Dose that was too-long in transit and was not suitable for use, no AE; Initial information received on 28-Sep-2020 regarding an unsolicited valid non-serious case from a Nurse Practitioner.  This case is linked to case 2020SA268090, 2020SA268092, 2020SA268094, 2020SA268089 and 2020SA268093 (same reporter).  This case involves a 83 years old female patient who was vaccinated with 0.7 ml once dose of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (prefilled syringes,lot number UJ498AA and expiration date:30-Jun-2021) via unknown route in the left deltoid for prophylactic vaccination on 28-Sep-2020. The vaccine was too-long in transit and was not suitable for use (PT: product storage error). It was reported that the boxes were cold but the ice packs were not hard frozen.  Medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications were not reported.  It was an actual medication error case due to incorrect product storage. As the vaccines that were not suitable for use were administered to the patients.  No adverse event reported at the time of reporting.  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.
Got the 1st of 2 shingles vaccine, injection site sore and swollen. Tired too.
The night of the first dose, my abdomen broke out with a red, raised, fine rash that came and went throughout the night, and all the other nights to this date. I got hot/ cold when the rash would appear. The rash only appeared at night. My left knee become a bit swollen, with fluid above the joint. It would get tight feeling with activity. The night of my 2nd dose, I broke out with a red, raised, bigger rash with open sores. This was on my abd, back, chest, thighs. It got worse with hot outside temperatures, and it was present day and night. This rash itched. My Left knee also got noticeably more swollen the night of my 2nd dose. I still have this and it is not getting better. It gets worse with movement. I just got my rash calmed down and very lessened, but it is still present to this day, but is not bad now.
extreme sleepiness approximately 5 hours after administration.  Sweats and lightheadness/dizziness  6 hours after vaccine.
Four days after injection, I became very ill. First with afib and then with bacterial endocarditis, which led to open heart surgery and replacement of the valve, two months of hospitalization and a month in rehab.
Patient was given his 2nd Pfizer vaccine 12 days before the recommended time between the 1st and 2nd dose.
Itching at injection site; Redness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itching at injection site) and VACCINATION SITE ERYTHEMA (Redness at injection site) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Itching at injection site) and VACCINATION SITE ERYTHEMA (Redness at injection site). At the time of the report, VACCINATION SITE PRURITUS (Itching at injection site) and VACCINATION SITE ERYTHEMA (Redness at injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Systemic: Numbness (specify: facial area, extremities)-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: By the time the patient left she stated that the tingling sensation and numbness was less dominant
This non-serious case was reported by a consumer via call center representative and described the occurrence of buttock pain in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a week after receiving SHINGRIX, the patient experienced buttock pain (Verbatim: Pain in right buttock area), rash (Verbatim: Skin rash that looked like infected cuts in right buttock/Infected cuts in skin her right buttock area), muscle spasm (Verbatim: Muscle Spasm) and shingles (Verbatim: Shingles outbreak). The outcome of the buttock pain, rash, muscle spasm and shingles were resolved (duration 3 weeks). It was unknown if the reporter considered the buttock pain, rash, muscle spasm and shingles to be related to SHINGRIX. It was unknown if the company considered the buttock pain, rash, muscle spasm and shingles to be related to SHINGRIX. Additional Information: GSK receipt date: 31-May-2023. This case was self reported by the patient. The patient received first dose of SHINGRIX vaccine about a month ago, date not provided) it was a Wednesday. Then the following week on Monday the patient developed pain in her right buttock area, muscle spasm and a skin rash that looked like infected cuts in her right buttock area. The patient stated that she was diagnosed with Shingles and it took 3 weeks to get rid of the symptoms. The adverse event was filed. No other information provided. The reporter consented to follow up.
Developed herpes infection on chin and neck, abated over 10 days; within 1 week after resolution developed herpes on torso treated with Valtrex 1 gm three times/day x 7 days (July 4th urgent care clinic thought it was Herpes Zoster), herpes resolved then within 2 weeks after completing 1 week course of Valtrex had reactivation herpes simplex Left opthalmic and redeveloped lesions on torso, treated by opthalmologist opthalmic herpes simplex resolved but persistant new herpes lesions on torso and arms, saw allergist, referred to specialist treated with another course of Valtrex 1 gm 3x/d x 10 days and currently on suppression therapy Valtrex 1 gm daily for 2-3 months
Noted 3"x3" area of redness, warmth, slight swelling and tenderness to left posterior arm at site where Varivax was administered.