chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Yesterday, injection site was swollen, itchy and warm to touch.; Yesterday, injection site was swollen, itchy and warm to touch.; Yesterday, injection site was swollen, itchy and warm to touch.; She had chills; She had headaches; Her left side of body was hurting for 4 days; Patient had sore right arm 12 hours after receiving 1st dose/ Her left side of body was hurting for 4 days.; She felt tingling in her left arm; warm to touch at injection site that comes and goes and still there; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN (Her left side of body was hurting for 4 days), PAIN IN EXTREMITY (Patient had sore right arm 12 hours after receiving 1st dose/ Her left side of body was hurting for 4 days.), PARAESTHESIA (She felt tingling in her left arm), VACCINATION SITE WARMTH (warm to touch at injection site that comes and goes and still there) and VACCINATION SITE WARMTH (Yesterday, injection site was swollen, itchy and warm to touch.) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included ATENOLOL and GEMFIBROZIL (LOPID) for an unknown indication.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 01-Mar-2021, the patient experienced PAIN (Her left side of body was hurting for 4 days), PAIN IN EXTREMITY (Patient had sore right arm 12 hours after receiving 1st dose/ Her left side of body was hurting for 4 days.), PARAESTHESIA (She felt tingling in her left arm), VACCINATION SITE WARMTH (warm to touch at injection site that comes and goes and still there), CHILLS (She had chills) and HEADACHE (She had headaches). On 24-Mar-2021, the patient experienced VACCINATION SITE WARMTH (Yesterday, injection site was swollen, itchy and warm to touch.), VACCINATION SITE SWELLING (Yesterday, injection site was swollen, itchy and warm to touch.) and VACCINATION SITE PRURITUS (Yesterday, injection site was swollen, itchy and warm to touch.). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN (Her left side of body was hurting for 4 days), VACCINATION SITE WARMTH (Yesterday, injection site was swollen, itchy and warm to touch.) and VACCINATION SITE PRURITUS (Yesterday, injection site was swollen, itchy and warm to touch.) outcome was unknown and PAIN IN EXTREMITY (Patient had sore right arm 12 hours after receiving 1st dose/ Her left side of body was hurting for 4 days.), PARAESTHESIA (She felt tingling in her left arm), VACCINATION SITE WARMTH (warm to touch at injection site that comes and goes and still there), VACCINATION SITE SWELLING (Yesterday, injection site was swollen, itchy and warm to touch.), CHILLS (She had chills) and HEADACHE (She had headaches) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
One week after receiving vaccination right deltoid area became itchy, bumpy, are hardened with slight discoloration
I thought my tinnitus, ear fullness was related to my long untreated BPPV and sought help for it. Tests showed I do have BPPV. They tested my hearing and I had new onset hearing loss in left ear. I realized I also had tinnitus and had been taking children?s Sudafed for new onset eat fullness. I had a brain MRI which was normal. I had several treatments for my BPPV and I continue to avoid positioning that has always caused that vertigo . However, I have continued high pitched tinnitus and some ear fullness. I started thinking of the possible causes and the vaccines came to mind. I see this has been list in many papers as a possible side effect. I have not reported my concern to my ENT. I suspended the canalith repositioning treatments as they cause,me,great anxiety.
2 days after the injection she noticed itching around the site of the injection. The following morning she had burning and swelling and the arm is hot to the touch. The injection site was noted to be in her mid humeral area, below the deltoid.
Developed a large rash that is hot, itchy and sore to the touch 12 days after vaccination that has not gone away
flush, rash to face, trunk, and generalized to bilateral lower extremities , intense  itchiness, throat itchiness  and was given Benadryl 25mg IM and took 20 -30 minutes to relieves the itching and hives subsided gradually
chills; feeling fatigued; loopy (Spacey); didn't feel right; hands were shaky; A spontaneous report 1was received from a health care professional concerning a 47-year-old female patient who received Moderna's COVID-19 vaccine and experienced chills, feeling fatigued (fatigue), loopy (Spacey) (Feeling abnormal), didn't feel right andhands were shaky (tremor).  The patient's medical history was not provided. Concomitant product use was not provided.  On 23-Dec-2020, the patient received their first of two planned doses of mRNA-1273 (Lot number was unknown) intramuscularly for prophylaxis of COVID-19 infection.  On 24-Dec-2020 the patient started to fell chills, she felt fatigued, loopy, didn't feel right, and her hands were shaky.  Lab results and treatments for the events were not provided.    Action taken with the second dose of mRNA-1273 in response to the event was not reported.   The outcomes of the events were chills, feeling fatigued (fatigue), loopy (Spacey) (Feeling abnormal) and didn't feel right was considered unknown and for hands were shaky (tremor) was considered as resolved on 24-Dec-2020.; Reporter's Comments: This case concerns a 47-year-old, female patient, who experienced a non-serious unexpected event of feeling abnormal- (loopy spacey), feeling abnormal- (didn't feel right) and tremor, and non-serious expected event of chills, and fatigue. The events occurred 1 day after first dose of mRNA-1273, lot # unknown. Treatment details 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.
Pt claims that 1 day after vaccination, arm felt sore and irritated.  She placed ice and took Benadryl.  She noticed that the red area was starting to spread and went to physician office.  Physician gave her abx and she says that arm redness is starting to go away.
Employee reports not being able to feel legs/walk, or know when she was using the bathroom 5/11/2019. She was hospitalized 5/11-5/18. Currently has to do therapy and has tingling all over her body. Unable to work.
Site: Pain at Injection Site-Severe, Systemic: Joint Pain-Medium, Additional Details: just pain in shoulder with limited range of motion
I had been post menopause for one year but after receiving my first shot started spotting 1 day later on and off .    2 weeks after the second shot started bleeding heavily and have now had 3 heavier than I have ever had periods 27/28 days apart
w/in 2-3 hrs pain thighs; pt given DTP shot; thigh stiffness, extreme immobility; leg now weight bearing, fever; swelling, redness cont;
A non-serious report of dosing error (FLUMIST administered to 22 month infant) has been received from a Registered Nurse concerning a 22 month old male. This case is submitted in accordance with MedImmune's post-marketing committment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. Medical history and concomitant medications were not reported. On 13-Oct-2008, the patient was "inadvertently" administered  a half dose of FLUMIST (single nostril). When it was discovered the patient was less than 24 months old, it was decided to not administer the other half dose. The patient showed no reactivity to the half dose. The clinic planned to administer TIV at that time and the booster later since this was the first time the patient received an influenza vaccine. There was no adverse event reported with this vaccination error; therefore; treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved
Patient reported having a seizure that was non convulsive.  Patient was no conscious, racing heart beat.  Seizure lasted 17 minutes.  Patient reported no vomiting or urinating during the seizure.
I woke up the day after my vaccine and felt very dizzy and fainted.  (I had other symptoms that I would've expected after the covid shot as well... mild fever, chills, etc.)
Headache, Myalgia, NauseaVomiting, fatigue and chills Narrative:  Other Relevant History:
Swollen at lymph nodes in the neck and chest; Sore throat; A spontaneous report was received from a consumer concerning a 53-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced swollen at lymph nodes in the neck and chest and sore throat.  The patient's medical history, is not provided by reporter.  On 14-jan-2021  the patient received their first of two planned doses of mRNA-1273 (Lot number: 025J20A) intramuscularly for prophylaxis of COVID-19 infection.  On 21-jan-2021 the patient reported swollen at lymph nodes in the neck and chest ,and sore throat.  No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.   The events, Swollen at lymph nodes in the neck and chest, and sore throat .  Based on comment, Sore throat and Swollen at lymph nodes in the neck and chest is Unlisted
Mother called in, states pt's right thigh red, puffy. Temp ranging 99.9-100.2. Giving Tylenol. Also pt having watery diarrhea yesterday (8/21/03) and today (8/22/03).
After needle was inserted into muscle the "push" mechanism on the syringe froze and would not deliver the liquid contents into the patient's arm.  The needle and syringe were removed and examined...looked ok but could not push the liquid out of the needle.  The patient agreed to a second needle stick in the same arm and  a new dose of vaccine was obtained from the refrigerator.  The second dose was administered successfully.  Attempts to follow up with the patient 2 days later were unsuccessful so it is not know if there were any adverse effects from the shot.
The day after the vaccine neck was sore then next day was really sore and could barely turn my head. Saw Dr. told to put heat on it and advised me to go to Physical Therapy. Starting Physical Therapy 10/5/2022.
LEFT HAND STIFFNESS; LEFT HAND SORENESS AND FINGERTIP PAIN; LEFT AND RIGHT ARMPIT PAIN; LEFT HAND AND FOOT CRAMPING; INTERMITTENT HEAD ACHES; PAIN BEHIND BOTH EAR; SWELLING IN BOTH ARMPIT, BEHIND BOTH EAR; WATERY EYES; DRIPPY NOSE; This spontaneous report received from a patient concerned a 73 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included allergic to mold.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1821286 expiry: 06-SEP-2021) dose was not reported, administered on 15-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 15-MAY-2021, the subject experienced watery eyes. On 15-MAY-2021, the subject experienced drippy nose. On 17-MAY-2021, the subject experienced pain behind both ear. On 17-MAY-2021, the subject experienced swelling in both armpit, behind both ear. On 17-MAY-2021, the subject experienced intermittent head aches. On 19-MAY-2021, the subject experienced left hand and foot cramping. On 23-MAY-2021, the subject experienced left and right armpit pain. On 30-MAY-2021, the subject experienced left hand stiffness. On 30-MAY-2021, the subject experienced left hand soreness and fingertip pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from watery eyes, and drippy nose on 16-MAY-2021, and left hand and foot cramping on 30-MAY-2021, and had not recovered from left hand soreness and fingertip pain, left hand stiffness, pain behind both ear, swelling in both armpit, behind both ear, intermittent head aches, and left and right armpit pain. This report was non-serious.
Patient presented to Clinic walk in for treatment. Injection site was red and warm to touch, pain, swelling. Dx: cellulitis. Plan: Treat with oral antibiotics, warm, moist compresses 2-4 times a day, rest and elevation.
head pounding; heart racing/ heart palpitations; body aches; Very loud tinnitus/ringing in ears; head pressure; nausea; lack of appetite; brain fog; slight dizziness; severe inflammation in sinuses, throat; severe inflammation in sinuses, throat; severe inflammation in sinuses, throat; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 24Mar2021 15:45 (Lot number: EN6205) at the age of 51 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient took concomitant medications. The following information was reported: SINUSITIS (non-serious), PHARYNGEAL INFLAMMATION (non-serious), OROPHARYNGEAL DISCOMFORT (non-serious) all with onset 2021, outcome "not recovered" and all described as "severe inflammation in sinuses, throat"; HEADACHE (non-serious) with onset 25Mar2021 01:00, outcome "not recovered", described as "head pounding"; PALPITATIONS (non-serious) with onset 25Mar2021 01:00, outcome "not recovered", described as "heart racing/ heart palpitations"; PAIN (non-serious) with onset 25Mar2021 01:00, outcome "not recovered", described as "body aches"; TINNITUS (non-serious) with onset 25Mar2021 01:00, outcome "not recovered", described as "Very loud tinnitus/ringing in ears"; HEAD DISCOMFORT (non-serious) with onset 2021, outcome "not recovered", described as "head pressure"; NAUSEA (non-serious) with onset 2021, outcome "not recovered", described as "nausea"; DECREASED APPETITE (non-serious) with onset 2021, outcome "not recovered", described as "lack of appetite"; FEELING ABNORMAL (non-serious) with onset 2021, outcome "not recovered", described as "brain fog"; DIZZINESS (non-serious) with onset 2021, outcome "not recovered", described as "slight dizziness". The events "severe inflammation in sinuses, throat", "severe inflammation in sinuses, throat", "severe inflammation in sinuses, throat", "head pounding", "heart racing/ heart palpitations", "body aches", "very loud tinnitus/ringing in ears", "head pressure", "nausea", "lack of appetite", "brain fog" and "slight dizziness" were evaluated at the physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of sinusitis, pharyngeal inflammation, oropharyngeal discomfort, headache, palpitations, pain, tinnitus, head discomfort, nausea, decreased appetite, feeling abnormal, dizziness.  Additional information: It was also reported that patient did not receive other vaccine in four weeks. No Other medications received in two weeks. Ae resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Patient took Oral Steroids as Ae treatment. Patient had no covid prior vaccination. Covid test was performed post vaccination on May2021 as Nasal Swab test which was negative. Patient had no known allergies.  No follow-up attempts are possible. No further information is expected.
7/25/17 3 PM rash appeared and disappeared to arms area. At bedtime, all gone. Denies any fever or difficulty breathing. 7/26/17 morning, no rash. 5 PM rash appeared and disappeared every 30 min to arms and legs, nothing on the face. Denies any fever or breathing difficulty. 10P rash started to appear to back, then to face. Taken to Emergency Room. 10:30P, BENADRYL given. 12 min. rash is gone.  Discharged from ER.  7/27/17 slept well. Rash comes and goes on body, face not affected. 1150 AM BENADRYL given.
Patient fainted and collapsed approximately 15 minutes after the flu vaccine was given. Paramedics were called on to the site and vitals are checked. All normal, except low blood pressure. Then the patient was taken to the nearest hospital by patient's husband.
Chicken pox. Seen 04/01 for RAD/clinical pneumonia and prescribed Zithromax, Prelone, and albuterol. Prelone discontinued on 04/03 when seen.
Information has been received from a mother concerning her son, with no pertinent medical history, who in August 1999 was vaccinated SC with a first dose of MMR II. In May 2002, when the patient was 4 years old, he received a second dose of MMR II. It was reported that "now the patient has autism." The mother reported that the patient was taking "antifungals, nutritional supplements and probiotics to treat the autism." It was reported that the patient was not taking any medication at the time of vaccination . According to the reporter autism was considered to be disabling. The outcome was reported as not recovered. Additional information has been requested.
Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 25-year-old female patient who received mRNA-1273  for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273  (unknown route) .5 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273  (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. The reporter stated that, their facility had not been able to download the digital data logger, they had been put on hold by the state at the moment. There had been no power outages that would have impacted the Moderna vaccine.  It was reported that, the facility was unable to download the digital data logger, they would need to treat this issue as a temperature excursion. The data logger was unable to download for the months of Dec-2021, Jan-2022, and Feb-2022. The reporter did not have any questions and wanted to report this to Moderna.  The reporter stated that no adverse reactions were reported by any patients.  No treatment medications were reported.
Full body rash. Started on torso, progressed outward to extremities and face and back. Rash was very red, raised, margins were very prominent and rash was warm to the touch. Rash lasted 2 1/2 weeks. Patient itched hives. Very low grade fever of 99.8 axillary on day 10 after vaccine. Pt taken to immediate care, no treatment. Patient seen by PCP on day 11, no treatment. Referred to Allergist, seen on day 13, no treatment.
Information has been received from a registered nurse and a patient care coordinator concerning a 19 year old female who in June 2007, was vaccinated intramuscularly with 0.5 ml of the first GARDASIL vaccine (Lot not reported), in 08-JUL-2008 received intramuscularly 0.5 ml of the second dose of GARDASIL vaccine (lot: 660555/0279X) in the right arm, and on 04-NOV-2008, 0.5 ml of the third dose intramuscularly (Lot: 659184/0843X) in the left arm. Concomitant therapy included CLARITIN and hormonal contraceptives (unspecified). In approximately July 2008, the patient developed white pale patches around injection site after the second dose. In approximately November 2008, the patient developed white pale patches around injection site on the left arm. The skin discoloration on the arm faded quite a bit but it is still there, while the patch on the left arm from November has not changed much. The patient also complained that the last dose has made her whole shoulder sore. At the time of reporting on 29-APR-2009, the patient's discoloration and shoulder sore were recovering. This is one of tow reports from the same source. Additional information has been requested.
12 hrs after receiving vaccine, he began to have hives and itching to left arm and left side of abdomen. Was at home and took BENADRYL 50mg. Saw NP on 10/26/16 with one 5x3cm whelp on left arm. Told to use topical steroid and oral antihistamine.
This spontaneous report as received from a health professional refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 12-NOV-2015, the patient was vaccinated with improperly stored (exposed to the following temperatures and cumulative time frames colder than 36 F: In September of 2015, the coldest temperature was 34 F for 346.7 hours (over 14 days); In October of 2015, the coldest temperature was 34 F for 492.6 hours for a total of 839.3 hours (35 days); In November of 2015, the coldest temperature was 34 F for 192 hours, for a total of 1,031.3 hours (43 days)) VAQTQ injection, 0.5 ml (lot # L018499, exp. date: 25-FEB-2017) (route and strength unspecified). No concomitant medications were reported. No adverse effects have been reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
2hr p/vax chills & fever ?temp, weakness, urine turned orange; next day felt better;Sunday devel cold sore & swelling & rash on lt side face & tenderness in neck;redness @ site;blood sugar 288;
Was fussy that night. Spiked temp at 1 am. Had a seizure at 9 am on 03/21/2014.
Patient's mother reported that she had a grand mal seizure about 2 hours after receiving her vaccination.  Patient has poorly-controlled epilepsy.
First episode ocular migraine- flashing zig zag shapes in right eye lasting about 30 minutes. Still groggy next morning.
10/29/2007 Small area erythema at site (about 1.5cm).
large local rxn w/diffuse redness, very intense;hosp for tx w/IV ATB & steroids;5MAY95 5cm raised tender circular area homogenous redness, chills, upper arm swelling;8MAY95 diffuse redness, inc swelling, inc pain w/movement;ATB coverage;
I had a headache. My tongue was swollen on 3/7 and I couldn't talk. I went to the ER and they gave me Claritin and another medicine and they sent me home. I went home and slept. my tongue felt like someone had cut it with razor blades. (not cuts visible, just an analogy). I am continuing to take Claritin and Tylenol for the headache.
6 hours after the shot I have weakness in my lip corner to cheek bone. It felt exhausted and constrained. The lower edge of my lip line seemed to be weakened.