chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Spot is warm to the touch after second vaccine dose; Arm soreness after second vaccine dose; COVID Arm after second vaccine dose; Little redness on on the arm at the injection site after second vaccine dose; Little swelling on the arm at the injection site after second vaccine dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Spot is warm to the touch after second vaccine dose), PAIN IN EXTREMITY (Arm soreness after second vaccine dose), VACCINATION SITE REACTION (COVID Arm after second vaccine dose), VACCINATION SITE ERYTHEMA (Little redness on on the arm at the injection site after second vaccine dose) and VACCINATION SITE SWELLING (Little swelling on the arm at the injection site after second vaccine dose) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027B21A and 027A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to at an unspecified dose. On 23-Apr-2021, the patient experienced VACCINATION SITE WARMTH (Spot is warm to the touch after second vaccine dose), PAIN IN EXTREMITY (Arm soreness after second vaccine dose), VACCINATION SITE REACTION (COVID Arm after second vaccine dose), VACCINATION SITE ERYTHEMA (Little redness on on the arm at the injection site after second vaccine dose) and VACCINATION SITE SWELLING (Little swelling on the arm at the injection site after second vaccine dose). At the time of the report, VACCINATION SITE WARMTH (Spot is warm to the touch after second vaccine dose), PAIN IN EXTREMITY (Arm soreness after second vaccine dose), VACCINATION SITE REACTION (COVID Arm after second vaccine dose) and VACCINATION SITE SWELLING (Little swelling on the arm at the injection site after second vaccine dose) outcome was unknown and VACCINATION SITE ERYTHEMA (Little redness on on the arm at the injection site after second vaccine dose) had resolved.
Patient wasn't sure if she was overreacting or not but thought her face may have felt funny, perhaps a little numb. She also thought her tongue was swelling but that she could also be imagining that because she wasn't really having trouble breathing. She got nervous and so thought maybe that was why she felt like her heart was beating fast. Patient did not seem to be in need of the EPIPEN because she was functioning at full capacity and breathing was fine. She did not have a rash.
Subcutaneous fat necrosis on the anterior right thigh.  Parents noted a mass in the thigh approx the size of a walnut approx 3 days after the vaccination.  She was acting well and there were no overlying skin changes.
Patient received Rotateq vacccine on 8/18/06 within 24 hours Dad developed vomiting and diarrhea.  He had no other known contacts.  The next day mom, grandmother, and grandfather also developed vomiting and diarrhea.  The patient developed vomiting and diarrhea 4 days after vaccination.  She required only oral rehydration.
No additional AE reported.; Administration of improperly stored vaccine on 15-SEP-2022.; This spontaneous report has been received from a health care business professional and refers to a 6-month-old patient. The patient's medical history, concomitant therapies and previous drugs reactions or allergies were not reported.  On 15-SEP-2022, the patient was vaccinated with first dose of an improperly stored haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) lot #T026960, expiration date: 17-MAR-2023, administered for prophylaxis (strength, and route of administration were not provided) following a temperature excursion of  35.2 degree Farenheit for 6 hours 12 minutes, it was stated that no previous temperature excursion occured. No additional adverse event was reported.
Severe Headache  -  for 2 days and took Tylenol,    Face Swelling - for 1 day and took  Benadryl,   Diarrhea - for 1 day,    Arm swollen and hot,  - for 1 day,   Body muscle pain  - for 3 days
Breakthrough case admission after 3 vaccines Pfizer 4/6/21 lot# EW0153;  Pfizer 5/4/21 lot# Ew0171;  Moderna 1/14/22 lot# 068H21A;
I am having tightness in my throat. It feels like a tonsils stone. But nothing is showing up on the screening. These has been happening for about 3 to 4 weeks now.  It was really painful around the 13th of October.  Now it is just a mild pain.  I went to a doctor about this. They tested me for Strep test, negative result.
Called PCP office about 2 weeks after given flu shot to ask if it was normal for my arm to hurt after the shot.  I was told to apply hot packs to my left arm and give it another week.  Did not improve and was sent to PT consultation on Oct 23, 2013 to start and started PT thereafter.
woke up on the 7/9 21 with jelled eyes that turned blood red . Difficulty breathing  also black around the eyes. Severe headaches.
J&J Dose 4/1/21 (lot NA) COVID Positive 1/3/22  1/17/22: A 76-year-old male with a past medical history of type 2 DM, hypertension, CAD, OSA comes to ED complaining of not feeling well.  Patient states that for the past 2 weeks has been feeling sick.  Initially it started as cold and chills.  Complains of feeling congested, with mild cough which is nonproductive, but denies chest pain or shortness of breath.  Patient has been feeling progressively weak.  He took a home COVID-19 test, and tested positive. He received monoclonal antibody infusion on 01/05/202.  He received Johnson and Johnson COVID vaccine in April 2021, has not received booster dose. Yesterday he noted his oxygen saturation was below 90, could not get it about 90, which prompted him to come to the ED.  patient states he was taking ever make 10 and hydroxychloroquine prophylactically before he tested positive and also for a few days after the positive test.   In the ED his temp was 100.8° F, pulse ox was 89% on room air, now on 3 L oxygen by NC, saturating 94%.  Blood work is significant for leukocytosis and elevated D-dimer.  CT angio chest is done and is reported as right middle lobe pulmonary embolism without right heart strain, diffuse pneumonitis/atypical pneumonia versus subsegmental atelectasis.  CT chest also reported bilateral renal pelvic nephrolithiasis, cholelithiasis with distended gallbladder, and findings concerning for exophytic dorsal right posterior liver lobe neoplasia.   Patient was given IV ceftriaxone and Zithromax in the ED, anticoagulation with Lovenox is initiated.  1/20/22: P.o. zinc sulfate, vitamin-C and vitamin-D  P.o. Eliquis 10 mg b.i.d. for 7 days then 5 mg twice a day afterwards  Continue on home p.o. metformin and glimepiride  P.o. azithromycin course  P.o. Decadron course  Hemodynamically stable for discharge  Will discharge home  Follow-up with PCP in 3-5 days  Patient agrees with plan of care
an expired Act-Hib inadvertently administered to an 9-month-old consumer with no reported adverse event; Initial information received on 13-Jun-2023 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 9 months old male patient who was administered an expired HIB (PRP/T) vaccine [ACT-HIB] inadvertently with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 25-May-2023, the patient received an expired dose 2 of suspect HIB (PRP/T) vaccine, powder and solvent for solution for injection (batch number: UJ665AAA; expiry date: 11-Mar-2023) via unknown route in unknown administration site for prophylactic vaccination (immunization), inadvertently with no reported adverse event (expired product administered) (same day latency).  Action: not applicable.  At time of reporting, the outcome was Unknown for the event an expired act-hib inadvertently administered to an 9-month-old consumer with no reported adverse 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 guidelines. 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.
Patient had left the building and was driving away when she suddenly felt lightheaded and her heart pounding. She came back to the clinic and we brought her back to the recovery area. Vital signs at 1530 were BP 130/84, P 95, RR 24, O2 100%. Had patient recline in a gurney and gave her water. After 25 minutes of resting, she reports feeling back to baseline. Instructed patient to call PCP/urgent care/ER if symptoms return or new symptoms occur. Instructed patient in the symptoms to call 911 for.
Hives on his rear; Slight fever of 100.1; This is a spontaneous report from a contactable consumer (Patient's spouse). A 98-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unknown date, the patient experienced a slight fever of 100.1, and patient received 2 Tylenol and it went away. It was also reported that he experienced hives on his rear end but they went away after receiving a Benadryl. The caller asked if the patient should receive the second vaccine dose given reaction to the first dose. The outcome of the events was recovered.  Information on the lot/batch number has been requested. Follow-up attempts are completed. No further information was expected.
Soreness in left arm; Redness around injection site/ redness increased to 3 inches; Felt hot around injection site; Hardness; Itchiness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Felt hot around injection site), VACCINATION SITE INDURATION (Hardness), PRURITUS (Itchiness), PAIN IN EXTREMITY (Soreness in left arm) and VACCINATION SITE ERYTHEMA (Redness around injection site/ redness increased to 3 inches) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical reported history).    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced PRURITUS (Itchiness). On 27-Jan-2021, the patient experienced VACCINATION SITE WARMTH (Felt hot around injection site), VACCINATION SITE INDURATION (Hardness) and VACCINATION SITE ERYTHEMA (Redness around injection site/ redness increased to 3 inches). On 28-Jan-2021, the patient experienced PAIN IN EXTREMITY (Soreness in left arm). On 27-Jan-2021, PRURITUS (Itchiness) had resolved. At the time of the report, VACCINATION SITE WARMTH (Felt hot around injection site), VACCINATION SITE INDURATION (Hardness), PAIN IN EXTREMITY (Soreness in left arm) and VACCINATION SITE ERYTHEMA (Redness around injection site/ redness increased to 3 inches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Rash and Hives moved to ER given iv benadryl , peptic and kept in observation for about 4 hours.  Discharged and given prescription for prednisone
Diffuse myalgias and joint pains including pleuritic chest onset approximately 36 hours after dose administered.  Resolved after another 24 hours.  Recurred again for < 24 hours and then resolved.
Lupus flare, intractable pain, chest pain; patient received prolonged infusion of ketamine
After the first dose, I experienced only mild fatigue and a mild headache within a couple hours of the injection. Later within 10 hours, I developed strong injection site direness that affected my sleep but abated within 12 hours. Therefore, I was expecting more or less similar symptoms with the second dose. Instead, I felt absolutely nothing for nearly twelve hours until I fondly felt mild injection site soreness. I went to bed around 1 am. At around 2 am I awoke with such strong chills that they were almost like convulsions. I was sweating and had a headache.  More concerning though was the tachypnea and wheezing. I was wheezing as if I had asthma to the point that my lunch?s were whistling and I found it difficult to take sufficient breaths. This lasted 30 minutes to one hour before a sting enough that I fell asleep again, still with mild left arm soreness, sweating, mild fever, headache and wheezing. When I awoke a few hours later at around 8 am, I was so fatigued that I could not move. I had a mild headache still but the breathing was better without wheezing and now only hampered by frequent belching (passing off the CO2 buildup from the tachypnea most likely). However, I was so exhausted that I lay in bed for another four hours. When I forced myself up to shower and move, I had a sudden severe depressive attack of uncontrollable crying in the shower. I also had body aches throughout the morning. These symptoms are the same or similar to those felt when I had COVID, so I knew them and that they should pass, yet I did not expect them to be so strong  and the tachypnea with wheezing was initially very disconcerting until it began to ease.  By approximately 11 hours later,  all symptoms had passed.
while the paramedics were w/daughter started c/o dizziness;paramedics had pt lay on floor & did transport to ER;pt became dizzy approx 15-20min p/vax;
product storage error; A nurse administered 4 doses of expired Moderna Covid-19 vaccine.; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (A nurse administered 4 doses of expired Moderna Covid-19 vaccine.) and PRODUCT STORAGE ERROR (product storage error) in an 82-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 032F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Feb-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 11-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (A nurse administered 4 doses of expired Moderna Covid-19 vaccine.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (product storage error). At the time of the report, EXPIRED PRODUCT ADMINISTERED (A nurse administered 4 doses of expired Moderna Covid-19 vaccine.) and PRODUCT STORAGE ERROR (product storage error) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Date the vial was initially stored in the refrigerator on 04-Feb-2022, 11-Feb-2022, 18-Feb-2022.  No concomitant medication information provided. No treatment medication information provided.   Most recent FOLLOW-UP information incorporated above includes: On 14-Apr-2022: Non-significant follow up
Patient was given Covid-19 Bivalent (grey top) vaccine on 03/27/2023 which was beyond the usage date of 01/11/2023. Patient has been notified. No adverse side effects. Report also filed with Pfizer and Agency. Awaiting response on efficacy from Pfizer.
Chills from about 8pm 1/26/2021 until 3am 1/27/2021 and then intermittent chills until 8pm 1/27/2021. Tachycardia - Heart rate in the 130s and 140s after doing simple tasks like brushing teeth; Heart rate in the 120s at rest on 1/27/2021. Intermittent profuse sweating 1/27/2021. Fatigue 1/26/2021 to 1/28/2021. Mild dizziness 1/26/2021. Nausea 1/27/2021. Headache 1/27/2021. Muscle aches 1/27/2021 to 1/28/2021. Joint pain 1/27/2021. Dehydration 1/27/2021 Lymphadenopathy on left side of body ongoing from 1st dose but got significantly larger after 2nd dose on 1/26/2021.  Still ongoing. Severe pain in the left deltoid 1/27/2021 that made it difficult to perform simple tasks and ADLs; Moderate left arm pain is ongoing. Highest temperature was 98.5 degrees, which is about 1 degree higher than normal for me.  However, I was taking Tylenol and Ibuprofen around the clock, so true temperature may have been masked. These symptoms rendered me unable to function at my job in the hospital and I had to go home from work on 1/26/2021 and 1/27/2021.  I took Tylenol 1,000mg q8h and Ibuprofen 600-800mg q8h on 1/26/2021 and 1/27/2021
Nausea and stomach cramping. Colon cramping. Lethargy. I'm tired.
101 - 103 fever, chills, headache, fatigue, and nausea for 24 hours. Severe injection site pain for 48 hours. Took Tylenol to treat pain and fever.
Patient developed a very large lump under the injection site on his leg. He also had a fever over 101 the night after he received his shots. The lump took around 3 days to go away. I called the office and was told it was normal and to watch to make sure it didn't get too much bigger.
An ACTHIB diluent was expired, and the powder was good. It was given to two patients after the expiration date with no reported adverse event; Initial information was received on 16-Mar-2023 regarding an unsolicited valid non-serious case received from a consumer/non-health-care professional.  This case involves 1 years old female patient who stated an acthib diluent was expired, and the powder was good. it was given to two patients after the expiration date with no reported adverse event after receiving HIB (PRP/T) vaccine [ACT-HIB].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included pneumococcal vaccine CONJ 13V (CRM197) (Prevnar 13) for Prophylactic vaccination.  On 14-Mar-2023, the patient received 0.5 ml Total dose of suspect HIB (PRP/T) vaccine (Powder and solvent for solution for injection) (lot: UJ642AA/U7247AB, expiry date: 27-Mar-2023/ 02-Mar-2023) (strength was unknown) via intramuscular route in Left thigh for Immunization.  On 14-Mar-2023 the patient developed a non-serious event of an acthib diluent was expired, and the powder was good. it was given to two patients after the expiration date with no reported adverse event (expired product administered) same day following the administration of HIB (PRP/T) vaccine.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event.  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.
There was no adverse event, patient took Moderna as first shot and came in today and received Pfizer as the 2nd dose.  performing the injection didn't know that the 2 vaccines were not to be mixeEd.
Upper Left Arm (on side where injection occurred) turned red, had heat in the muscle and seemed slightly swollen over the entire upper left arm muscle and remains that way seeming worse as of 9/24/2014.  It looks as though it is a giant hive.
Localized erythema to Left upper outer arm.  Bull's eye type lesion measuring 6.5cm x 7 cm. Patient also c/o of mild headaches.
Headache, Fever, FATIGUE, ACHINESS IN ARM; BODY ACHES Narrative: STATES HEADACHE HAS PERSISTED FOR 5 DAYS
Nausea at 8pm, extreme chills at 830pm, fever of 101.4 at 1030pm taken Tylenol pill.
Immediately after vaccination: Fever, headache, muscle weakness, fatigue. One week after vaccination: loss of appetite, explosive diarrhea, fatigue.
neuropathy in her legs after taking the covid vaccine.; This is a spontaneous report from a contactable physician. A adult non pregnant female patient received BNT162B2 (COVID-19 VACCINE - MANUFACTURER UNKNOWN, Lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications was not reported. It was unknown if the patient receives any other vaccines within 4 weeks prior to the COVID vaccine and other medications the patient received within 2 weeks of vaccination. It was unknown whether the patient was diagnosed with covid prior to vaccination or was tested for COVID-19 post vaccination. The patient experienced neuropathy in her legs after taking the covid vaccine. Patient was seeing neurologist, who said that he is seeing several patients who are experiencing neuropathy after their covid shots. The reporter was not sure which vaccine patient took. The patient did not receive any treatment in response to the event. The outcome of the event was not recovered.    The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Based on the information provided in the narrative, a causal association between the suspect drug and peripheral neuropathy cannot be completely excluded. 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.
9/28 24-36 hrs later site became swollen red, irritated and tender with chills, fever up to 105 for 24 hrs.
Vaccine did hit me hard the day after, all day Friday, and managed as many naps as possible but keeping G?s routine going. As the night went on, I found it more difficult to stay awake. I experienced something I have not experienced in almost 20 years. I suffered from a few bouts of sleep paralysis in my 20s. It was horrifying to be awake and unable to move a muscle and you can even make a sound. Last Friday, I literally stopped breathing (never happened b4) and woke up paralyzed just for a few moments and when I regained movement, I was gasping for air. I was so scared because it kept happening shortly after falling asleep but I could not stay awake. I am not sure if my fibromyalgia played a part in this or not.  I have also been experiencing more shortness of breath since then and the last two days constant ear ringing.  It is hard to focus with the high pitch ringing in my ear. I am out of breath with such little movement required.
Onset of weakness left shoulder approx 4 days after receipt of AVA booster SC in skin over right deltoid. Pt reported to clinic on 07/01/03. Examination revealed 4+15 weakness of abduction at 45 degrees of right shoulder extension. No sensory loss. DTRs normal. Plantars, no tingling, numbness. Spine WNL.