chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The logistician from station 3 alerted the observation area that a patient was not feeling well.  The patient was sitting on the chair. She looked pale.  She complained of feeling dizzy and lightheaded (went away 2 mins after getting the shot) and blurry vision (went away 5 seconds after getting the shot) Blood pressure: 118/76; Pulse 68. O2 sat unable to read d/t nail polish. Good capillary refill. She felt better after 20 minutes. She rested laying down with her feet elevated for 20 minutes. She sat down for 15 minutes and stood up for 5 minutes with no dizziness/lightheadedness. Patient texted that she arrived home safely and felt fine.
Started getting an itchy large red rash at the site of the vaccine injection (upper arm), in addition to headaches in the mornings and at night.
Beginning of this year, my left hand and arm started going numb, pins and needle with numbness sensation. I went to my doctor who referred me to do physical therapy which made it worse. I had appointment on Friday 04/22/2022 to see a pain management specialist who will be performing an MRI.
Right upper deltoid area with 4 1/2 x 3" cm erythemic, swelling, warm to touch, pruritic.
pain in the arm of the injection; hot flashes; feeling very sick; it hurts; chills; eleven days apart between the two doses of the vaccine; A spontaneous report was received from a consumer concerning a 64-year-old, female patient who received Moderna's Covid-19 vaccine (mRNA-1273) and experienced pain in the arm of the injection (Pain in extremity), chills, hot flashes (hot flush), it hurts (Injection site pain), feeling very sick (illness) and eleven days apart between the two doses of the vaccine (Inappropriate schedule of product administration).  The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event, included supplements.  On 08-Jan-2021 the patient received their first of two planned doses of mRNA-1273 (Lot number: not provided) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 19-Jan-2021 the patient received their second of two planned doses of mRNA-1273 (Lot number: not provided) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  A consumer who is the patient called to report she received her second dose of the Moderna COVID-19 vaccine eleven days apart. From 19-Jan-2021, the patient started feeling pain in the arm of her injection, chills, hot flashes and felt very sick. No treatment had been taken for the events.  Action taken with mRNA-1273 in response to the events was not provided.   The event eleven days apart between the two doses of the vaccine was considered resolved on 19-Jan-2021. The remining events, pain in the arm of the injection, Injection site pain, chills, hot flashes and feeling very sick, were considered resolved on 20-Jan-2021.; Reporter's Comments: This case concerns a 64 years old female patient, who experienced inappropriate schedule of product administration, and a non-serious unexpected event of pain in extremity, hot flush, illness, and non-serious expected events of injection site pain, and chills. There were no reported AEs associated with this case of inappropriate schedule of product administration. The events (pain in extremity, hot flush, illness, injection site pain, and chills) occurred 1 days after second dose of mRNA-1273, lot # unknown. Treatment details was not provided. Based on the current available information and temporal association between the use of the product and onset of the events a causal relationship cannot be excluded.
This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient. A 49 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date Jan2021 (Batch/Lot number: unknown) at the age of 49 years as dose 1, single for Covid-19 immunisation. Relevant medical history included: "CKD" (unspecified if ongoing); "hypokalemia" (unspecified if ongoing); "Known allergies: yes" (unspecified if ongoing). Concomitant medication(s) included: K Citrate; Aldactone [Spironolactone]. The following information was reported: ARTHRALGIA (non-serious), MYALGIA (non-serious), outcome "not recovered" and all described as "Severe full body joint and muscle aches"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious), outcome "not recovered", described as "have lessened in severity but limiting activities"; FATIGUE (non-serious), outcome "not recovered", described as "fatigue". Therapeutic measures were not taken as a result of arthralgia, loss of personal independence in daily activities, myalgia, fatigue. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. Follow-up (07Oct2021): New information received from a contactable other HCP included no new information.
anaphylactic reaction / throat was closing / rashes; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): 2022NVX-US-000002880 (Novavax).  A female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ANAPHYLACTIC REACTION (medically significant), outcome "unknown", described as "anaphylactic reaction / throat was closing / rashes".  Clinical course: On 04Aug2022, it was reported that a patient started treatment on an unspecified date with Pfizer Biontech Covid-19 Vaccine at 'shot 1' for an unspecified indication. It was reported the patient had an anaphylactic reaction, throat was closing, and rashes were coming out. No further follow-up is anticipated  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
accidentally gave a pediatric dose of Hep B to an adult; accidentally gave a pediatric dose of Hep B to an adult; This case was reported by a nurse via call center representative and described the occurrence of adult use of a child product in a adult patient who received HBV (Engerix B pediatric) for prophylaxis.   Co-suspect products included HBV (Engerix B pediatric) for prophylaxis.   On an unknown date, the patient received the 1st dose of Engerix B pediatric and the 2nd dose of Engerix B pediatric. On an unknown date, unknown after receiving Engerix B pediatric and not applicable after receiving Engerix B pediatric, the patient experienced adult use of a child product and adult use of a child product. On an unknown date, the outcome of the adult use of a child product and adult use of a child product were unknown.  Additional details were provided as follows: Age at vaccination was not reported. Nurse reported that clinical medical assistant (CMA) accidentally gave a pediatric dose of Hep B to an adult, which led to adult use of a child product. The Nurse PR actioner ended up ordering a second dose of the pediatric Hep B to equal the adult dosage.  The reporter asked was there any considerations or any additional doses the patient would need. No additional information available at this time. Outbound call made in attempts to gather information for adverse event, but health care professional was not available.
VR experienced nausea and vomiting a few minutes after vaccination. VR appeared diaphoretic and pale.  Symptoms subsided after 5 min.
Itching, swelling, and redness apx. 3inches in diameter  about 2 inches below injection site.
The patient felt dizzy, nauseated, nervous and was very pale. The patient rested and was reassured.
Chest tightness and breathlessness immediately after the vaccine was administered. The pharmacist said to take Aspirin or Ibuprofen. Later developed fever (102F) and severe pain in right arm, which resolved after 3 days. However, breathlessness after even slight walking continues as of 8th day. Also developed dry cough on 4th day, needing nebulization. This is typical allergic reaction for the patient after exposure to allergens. RT-PCR test was negative on the day before the vaccine. Had completed both doses of MODERNA in another Country as of 7/2/21, but took Moderna because the school required a approved vaccine. Called Health Services and informed about the symptoms.
patient states that starting 4 to 5 days after injection she had pain slightly below injection site and in her left leg as well. This resolved with Physical Therapy but now experiencing shooting pain in all extremities without weakness . On Gabapentin with minimal relief.
21-year-old male presents to emergency department with complaints of left-sided chest discomfort since last night.  Complains of a dry cough as well as nausea, sore throat and a mild frontal headache.  He denies any fevers or chills.  He is not taking any medications for cough.  States that he has been drinking Pedialyte.  Has not taken any medications for pain.  Describes the chest discomfort as a dull ache but tolerable.  He denies any known exposure to Covid.  States that he took 2 at home Covid test this morning which were negative.  He denies any vomiting 1. Acute URI J06.9   Afebrile, nontoxic-appearing.  Respiratory distress or hypoxia noted.  Patient does have a dry cough.  No wheezing or adventitious breath sounds noted on examination.  Patient describes some mild left lower chest wall discomfort.  Triplex Covid/flu test performed, negative for Covid and influenza.  Suspect viral URI.  Discussed supportive measures at length with the patient.  Instructed the patient that he may take over-the-counter Mucinex or Robitussin as needed for cough.  May take over-the-counter Tylenol or ibuprofen as needed for pain.  Advised to return back to the emergency department for fever to the 101, coughing up blood or any new or worsening symptoms.  Patient verbalized understanding and agreed to plan of care.   2. Pleurisy R09.1     Orders:   XR Chest 1 View Portable, 03/15/22 9:50:00, Routine, 03/15/22 9:50:00, SOB, No, Transport Mode: Walk, , Yes, , No, Rad Type
GAVE 3RD DOSE OF MODERNA WHICH HAS NOT BEEN APROVED BY CDC YET
Left arm was sore after the booster dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Left arm was sore after the booster dose) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019F21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: FLU VACCINE VII (The patient reports that the big reaction that she had to the first shot was similar to a high dose flu vaccine she received before the Moderna .). Past adverse reactions to the above products included Vaccination adverse reaction with FLU VACCINE VII.    On 22-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In October 2021, the patient experienced VACCINATION SITE PAIN (Left arm was sore after the booster dose). At the time of the report, VACCINATION SITE PAIN (Left arm was sore after the booster dose) outcome was unknown.      No relevant concomitant medications was reported. Treatment information was not provided.   This case was linked to MOD-2021-060017, MOD-2021-063941 (Patient Link).
A 51-year-old female patient, whose medical history and concomitant medications were not reported, had received intramuscular second dose of ADACEL in right deltoid (lot number U4305AA) on 01 May 2012. The patient had received first dose of ADACEL on 18 September 2011. On 23 April 2012, the patient had complaint that her titanium knee replacement feel as if they were on fire. She was unable to get relief from any medications. It was reported that, the patient inadvertently received a second dose of ADACEL seven months after the first dose. The outcome of events was reported as not recovered. Documents held by sender: none.
Patient was to receive monovalent primary series pfizer dose 2 but incorrectly received Bivalent booster instead.   Pt's parent was notified on event.  No side effects reported.
Intermittent right jaw spasm which increased with frequency, difficulty opening mouth and chewing on right side, felt like my jaw was going to lock up in place. These symptoms lasted for four days. Also expected symptoms of fever 100.4, generalize body and joint pain, malaise, chills.
Young African American female given flu shot and within 2 hours developed mild left posterior swelling of tongue and inflammation to left bicep. Shot administered at 1300 and reaction noted by 1500 on 12/01/2001.
Left side of my breast was hurting; This is a spontaneous report from a contactable consumer, the patient. A 35-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ew0191) via an unspecified route of administration in the left arm on 29May2021 (at the age of 35-year-old) as a single dose for COVID-19 immunisation. Medical history included blood pressure abnormal. The patient took blood pressure medications within two weeks of vaccination. 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. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ew0168) via an unspecified route of administration in the left arm in 2021 at 13:15 (at the age of 35-year-old) as a single dose for COVID-19 immunisation. On 22Jun2021 at 14:30, the patient noticed that left side of her breast was hurting. No therapeutic measures were taken as a result of event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event left side of her breast was hurting was recovered at the time of this report.
28JAN93 devel hive on cheek (mom describes wheal & flare); w/in 1 hr it flattened then to sitter; fine all day; 5PM that evening devel another red spot progressed to a big hive devel more on nose then ear, chin, legs; called MD;
Medical assistant gave a hepatitis B vaccine to the 3 month old patient who was here for his 2 month physical but she was not aware that baby had already gotten his second hepatitis B vaccine on his 1 month old physical in May 2021 so basically this hepatitis b vaccine was not needed and he will still need to get another at his 6 month check up
High fever 101; Headache; Sore muscles; Chills; Redness at vaccine site and belowthe shot; 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 PYREXIA (High fever 101), HEADACHE (Headache), MYALGIA (Sore muscles), CHILLS (Chills) and VACCINATION SITE ERYTHEMA (Redness at vaccine site and belowthe shot) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (High fever 101), HEADACHE (Headache), MYALGIA (Sore muscles), CHILLS (Chills) and VACCINATION SITE ERYTHEMA (Redness at vaccine site and belowthe shot). At the time of the report, PYREXIA (High fever 101), HEADACHE (Headache), MYALGIA (Sore muscles), CHILLS (Chills) and VACCINATION SITE ERYTHEMA (Redness at vaccine site and belowthe shot) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101 (High) High fever 101.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.   No treatment information for the events was provided.
discomfort at injection site, fever and viral prodrome next day papular rash 5 days later
Felt something was wrong; Felt light headed / Felt like he could pass out; Shaky hands like never before; Sweating while driving; Slept a lot; Extremely tired / couldn't even sit up for a meeting he was so tired; Struggled to get through work; A little groggy; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (A little groggy), IMPAIRED WORK ABILITY (Struggled to get through work), FEELING ABNORMAL (Felt something was wrong), DIZZINESS (Felt light headed / Felt like he could pass out) and NERVOUSNESS (Shaky hands like never before) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 05-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-May-2021, the patient experienced SOMNOLENCE (A little groggy). On 07-May-2021, the patient experienced IMPAIRED WORK ABILITY (Struggled to get through work), HYPERSOMNIA (Slept a lot) and FATIGUE (Extremely tired / couldn't even sit up for a meeting he was so tired). On an unknown date, the patient experienced FEELING ABNORMAL (Felt something was wrong), DIZZINESS (Felt light headed / Felt like he could pass out), NERVOUSNESS (Shaky hands like never before) and HYPERHIDROSIS (Sweating while driving). At the time of the report, SOMNOLENCE (A little groggy), IMPAIRED WORK ABILITY (Struggled to get through work), FEELING ABNORMAL (Felt something was wrong), DIZZINESS (Felt light headed / Felt like he could pass out), NERVOUSNESS (Shaky hands like never before), HYPERHIDROSIS (Sweating while driving), HYPERSOMNIA (Slept a lot) and FATIGUE (Extremely tired / couldn't even sit up for a meeting he was so tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement (98-52): 98/52 (Low) Blood pressure was low 98/52. On an unknown date, Heart rate: 47 (Low) Pulse rate 47.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication use information was not provided by reporter.   Patient went running with his wife and son 4 miles, got 2 miles and felt something was wrong. Once got home and rested, started doing things around the house and patient was lifting a screw driver, noticed his hand was shaking so bad he had to get his son to hold the screw steady because of shaking of hand. patient ate and felt a little better, went back home. Patient stopped exercising , running, and weights but continued walking one mile three times a day . Had a running event  was trying to train  but couldn't get his endurance back,  this lasted 4 weeks. Heart and lungs and everything was good. Doctor tried a heart monitor for two months tried to return normal, Scheduled for an eco cardiogram.  Treatment medication use information was not provided by reporter.
Pt. states that after receiving the 3rd dose of Pfizer 01/04/2022, started experiencing symptoms 02/01/2022 of "cold" symptoms, developing difficulty breathing. 02/13/2022 Emergency Room visit, Blood Panel, Cat-Scan determined "Infection" in the Lungs. Treated with Steroids Prednisone and over the counter Tylenol.
This spontaneous prospective pregnancy report was received from a healthcare student, who is also a female patient of unknown age and was reporting on herself. Her last menstrual period (LMP) was on 27-OCT-2015 and estimated delivery date (EDD) was 02-AUG-2016, based on the information provided by the reporter that she was 6 weeks pregnant on 09-DEC-2015. There was no information about the patient's concomitant therapies or medical history provided. On an unknown date, the patient was vaccinated with her second dose of GARDASIL (strength, dose, route of administration, lot # and expiration date were not reported). On 07-DEC-2015, the patient was vaccinated with a dose of VAQTA (strength, dose, route of administration, lot # and expiration were not reported). There was no adverse effect reported. The patient sought medical attention by scheduling an appointment with an obstetrician / gynecologist to discuss the administration of both vaccines. The outcome of exposure during pregnancy was unknown. Additional information has been requested.
Information has been received from a nurse concerning a 22 year old female patient with a history of hypothyroidism, migraine and neurocardiogenic syncope and with no drug reactions/allergies who in August 2009 was vaccinated IM with the fires 0.5 ml dose of GARDASIL vaccine. Concomitant therapies included SYNTHROID and MAXALT. Subsequently the patient experienced nausea, vomiting and numbness of the right arm post vaccination. The patient had sought unknown medical attention. There were no lab diagnostic studies performed. At the time of report the patient's status was recovered. Additional information has been requested.
swelling, rash, and hives on left side of body appearing 24 hrs after injection.  Treated with Benadryl and epinephrine.  Resolved within 24 hrs.
PATIENT DEVELOPED REDNESS TO INJECTION SITE (RIGHT ARM) WITH INDURATION AND SENSITIVE TO TOUCH
This spontaneous report as received from a nurse refers to a patient of unkonwn age and gender. Medical history and concurrent conditions were not reported. On an unknown date in 2004, the patient was vaccinated with the first dose of VARIVAX (Merck) 0.5 ml, subcutaneous (lot number was not reported). On an unknown date in 2007, the patient was vaccinated with the second dose of VARIVAX (Merck) (dose, strength frequency, route and lot number were not reported). On 22-AUG-2014, the patient was vaccinated with the third dose of VARIVAX (Merck) lot # J013905, expiration date 30-OCT-2015 in the arm (dose, strength and route were not reported). The nurse reported that the patient received a third dose of VARIVAX (Merck) due to lack of documentation of the second dose of VARIVAX (Merck) at the time of the office visit. No adverse effect was reported. This is one of two reports received from the same source. Additional information has been requested.
New onset leukopenia/neutropenia with fever, unclear if related to vaccination, but temporally occurred the day after receiving 1st dose. No labs immediately prior to vaccination, so leukopenia may have preceded vaccine. No other new medications to explain neutropenia. Off chemotherapy since 8/2020. Possible relapsed disease though no other evidence in support of this as remainder of CBC stable.
Systemic: Allergic: Itch Generalized-Mild, Systemic: Allergic: Rash Generalized-Mild, Additional Details: Patient did not want to take benadryl. will take allegra
Bitter taste in mouth that came on suddenly and distinctly approximately 20 minutes post injection, and persisted for >1 week.  Symptom level:  mild.
This case was reported by a healthcare professional and described the occurrence of injection site redness in a 5-year-old female subject who was vaccinated with Infanrix, GlaxoSmithKline. Concurrent medical conditions included latex allergy. The subject had no adverse events following receipt of prior immunizations. There were no concurrent medications. On 12 March 2007 at 10:30 a.m., the subject received 5th dose of Infanrix in the right arm. On 12 March 2007, the subject also received injections of IPOL vaccine (Aventis Pasteur), MMR II and a PPD (Parkdale) skin test at unspecified sites of administration. On 13 March 2007, 1 day after vaccination with Infanrix, the subject experienced redness, swelling, and pain at the injection site of Infanrix and "down the subject's arm about 5 cm." The subject was seen at a physician's office and was treated with cephalexin (Keflex). The reporter considered the events to be due to potential quality issue for this lot of Infanrix. The outcome of the events was not reported.