chrisvoncsefalvay/vaers-outcomes huggingface dataset:
sore arm; Large pink spot; Itchy arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), INJECTION SITE DISCOLOURATION (Large pink spot) and PRURITUS (Itchy arm) 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 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm), INJECTION SITE DISCOLOURATION (Large pink spot) and PRURITUS (Itchy arm). At the time of the report, PAIN IN EXTREMITY (sore arm), INJECTION SITE DISCOLOURATION (Large pink spot) and PRURITUS (Itchy arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not reported.  Treatment information was not provided.   This case was linked to MOD-2021-037749 (Patient Link).
Given 12 mo vaccines on 4/24/09.  Initially had a knot (no reddness or drainage) at site of PCV + VZV shots.  She now has some redness of skin with serosanguinous drainage & lesion leg.  Meds prescribed:  Clindamycin plamitate 75mg/5m/granules Hydroxyzine HCL 10mg/5m/syrup.
dizzy; ell like she was going to pass out; felt like a panic attack; felt very sleepy; lost her autonomy; She couldn't walk or control her sphincters (she peed all over her); This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizzy), MALAISE (ell like she was going to pass out), PANIC ATTACK (felt like a panic attack), SOMNOLENCE (felt very sleepy) and FLAT AFFECT (lost her autonomy) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced DIZZINESS (dizzy), MALAISE (ell like she was going to pass out), PANIC ATTACK (felt like a panic attack), SOMNOLENCE (felt very sleepy), FLAT AFFECT (lost her autonomy) and GAIT DISTURBANCE (She couldn't walk or control her sphincters (she peed all over her)). The patient was treated with DIAZEPAM at an unspecified dose and frequency. On 06-Mar-2021, PANIC ATTACK (felt like a panic attack) had resolved. On 07-Mar-2021, DIZZINESS (dizzy), MALAISE (ell like she was going to pass out), SOMNOLENCE (felt very sleepy), FLAT AFFECT (lost her autonomy) and GAIT DISTURBANCE (She couldn't walk or control her sphincters (she peed all over her)) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided.
REGRESSION...STOPPED SAYING ONE/TWO SYLLABLE WORDS, IDENTIFYING THINGS HE WANTED, POTTY-TRAINING, HITTING HIMSELF, UNCONTROLLABLE OUTBURSTS, STARING OFF AS IF IN A TRANCE.
Extreme arm soreness (as if someone was hitting my arm with a bat repeatedly for first two hours after shot; prickly skin as if I had a low grade fever, headache, sensitivity to light, fatigue, aches all over- headache and sense of fever for two days, aches and soreness for 3 days.
Was vaccinated with Moderna COVID-19 Vaccine EUA Six days after vaccination, the location where the shot was made is now swollen, itchy and warm to the touch. I am treating area with ice and Benadryl lotion.
Ear infection and tinnitus lasted longer than 2 weeks.  Utilizes drops for 6 days then was moved to amoxicillin 500 mg with Sudafed. Still no relief after 4 days. Switched Zyrtek to Zyzal
swollen lymph nodes in armpits; This is a spontaneous report from a contactable consumer (patient). A 71-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Batch/Lot number and Expiration date were not reported), via an unspecified route of administration on 20Feb2021 11:00 as 1st dose, single dose for COVID-19 immunisation. The patient's medical history was not reported. Concomitant medication included unspecified blood thinner, taken for an unspecified indication, start and stop date were not reported. Prior to vaccination, the patient has not been diagnosed with COVID-19. The patient didn't receive any other vaccines within 4 weeks prior to COVID vaccine. The patient previously took DEMEROL and experienced allergy. The patient experienced swollen lymph nodes in armpits on 03Mar2021. No treatment was received for the event. Since the vaccination the patient has not been tested for COVID-19. The outcome of the event was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
1st dose only side effect was sore injection site -  2nd dose- 14 minutes after injection  near syncope episode  with severe dizziness, nausea, tachycardia, high blood pressure. Benadryl 50 mg  was administered. 45 minutes after Benadryl administration driven home and severe dizziness was present  until next morning. 17  hrs post injection had severe flu like symptoms (chills, severe headache, muscle/body aches/no fever). Took Advil 800mg. At 48hrs no symptoms remain. At 69 hrs post injection had severe dizziness that is still present at 72.5 hrs post injection.
Patient developed cough the day after vaccination. Symptoms worsened so the patient consulted a doctor on 11-2-17. She was diagnosed with severe bronchitis and was prescribed LEVAQUIN and Albuterol.
DEAD; This spontaneous report received from a consumer concerned a 24 year old female with an unspecified race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose, with frequency time 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, reporter said that after vaccination his cousin was dead. It was unknown, if an autopsy was performed. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient died from an unknown cause of death. This report was serious (Death). This case, from the same reporter is linked to 20211014628 and 20211014652.; Sender's Comments: V0:20211014552-covid-19 vaccine ad26.cov2.s-dead. This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
The Moderna vaccine was administered past its expiration date. We contacted Moderna , the mfg, who performed an analysis of the lot #043H22A, They determined: "the vaccines administered from June 9, 2023 to July 5, 2023 maintained the activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at the time of the administration."
Reaction to (L) SQ area with redness, fever to touch, raised measured approximately 40mm x 40mm Dr. notified and gave patients' mother instructions to apply cold compresses and take BENADRYL and ER warning given if any complications.
Felt out of sorts. Repeatedly asked ?what happened ?? Taken by ambulance to hospital shortly after 1pm. Memory returned about 4:30 pm while finishing CTA. All cognitive testing normal after 4:30pm
Left leg edema lasted approximately 1 week, Have not had a menstrual cycle after receiving the covid vaccine.  Pregnancy test is negative
The morning after the vaccine, woke feeling tired, some nausea and returned to bed without breakfast. Remained in bad all day with severe shaking and chills about  2:30 PM. Pharmacist suggested Tylenol so took one then to bed. Cold and shivering. Temperature by digital thermometer 101 but steadily increased to 103 deg F by 3:30 PM. Tired, in bed, nauseous, slight head ache and temperature began to decrease at 4 PM down to and holding at 101.2 by 6 PM. Not able to complete supper and back to bed at 6:20 PM. More minor chills, feeling poorly , tired with some burping and no energy. This morning, 7:30 AM feeling some better but tired and temperature  99.5.  My vaccine results were minor but gave tired feeling beyond normal for one day after the vaccine.
Got the 2nd Shingrix shot at about 10:30AM today (10/07/19).  Immediately swollen.  Slightly tender.  Have seen this before. Before going to bed, had headache.  Checked reactions to Shingrix vaccine, and swollen, tenderness, redness, headache, muscle pain.  Thought headache could be due to shot.  Went to bed at about 10:30 and woke up at 12:30, feeling very hot and pulse was fast though I should have been relaxed.  Hoping it would go away, but decided to get up and check temp, BP. Temp was 100.5F and my resting pulse was 156 and BP was 141/82.   Went to ER at about 2am, 10/08/19.
I had an increased heart rate, my heart rate after getting vaccine was 69 to 80 and then it's been staying between 100 and 115; This is a spontaneous report from a contactable consumer or other non-HCP. A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on 07Aug2021 (Age of vaccination: Unknown) as DOSE 1, SINGLE for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On 08Aug2021 the patient had an increased heart rate, also heart rate after getting vaccine was 69 to 80 and then it's been staying between 100 and 115. The patient underwent lab tests and procedures which included heart rate: 69 to 80 on an unspecified date, heart rate: between 100 and 115 on an unspecified date, heart rate: increased on an unspecified date. The outcome of event was unknown. Information about Lot/Batch number is requested.
fever of 101.8 8 hours after vaccine fever if 106.0 24 hours after vaccine
DO NOT KNOW BRAND OF RSV VACCINE RECEIVED...........  Reactions:  feeling of liquid in front teeth, numb & swollen lips, tiredness, aches - mild symptoms but mouth symptoms are strange..  Tylenol relieved aches but not mouth problems. Swollen upper lips persisted - still there 2 days later after RSV shot.  This reaction also happens after other vaccinations but this time they are milder.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15Oct2021 at 15:45 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 56 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Chronic kidney disease" (unspecified if ongoing). There were no concomitant medications, reported as no other medication in 2weeks. The patient had no known allergy. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid started on 02Sep2022 and stopped on 07Sep2022. Clinical course was reported as, The patient had a rebound of Covid-19 symptoms on 11Sep2022 at 08:00, 4 days after completing treatment. Patient not recovered from rebound symptoms.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Information has been received from a physician concerning "an around 60 year old" male who in 2010 was vaccinated subcutaneously with a single 0.65ml dose of ZOSTAVAX (Merck) (lot# not reported). Concomitant vaccination included a dose of seasonal influenza virus vaccine (unspecified) (name and manufacturer unspecified). Two hours later the patient experienced transient ischaemic attack. The patient was referred to a neurologist. At the time of the report, the patient's outcome was unknown. Transient ischaemic attack was considered to be disabling and immediately life-threatening. Additional information has been requested.
1.1 inch wide by 2 inch long, hot red rash where imm was given, hot to touch, soreness when touched noted 8 hours after imm. given. Denies SOB.
Patient fainted fell from chair with seizure like posture in less than 1 minute after administering vaccines.
Right leg at injection site 4cm round, red, warm, slightly tender welts with hives. Treated with cool compresses/Motrin for discomfort.
HEADACHE; MILD OVER ALL ACHY FEELING; INJECTION SITE WAS RED AND SWOLLEN; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, expiry: UNKNOWN) dose was not reported, administered on 01-APR-2021 to right arm for prophylactic vaccination. No concomitant medications were reported. On 01-APR-2021, the subject experienced injection site was red and swollen. On 02-APR-2021, the subject experienced mild over all achy feeling. On 07-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from mild over all achy feeling, was recovering from injection site was red and swollen, and had not recovered from headache. This report was non-serious.
Nausea, vomiting, dizziness, body aches, fever, headache, soreness at injection site.  These all began around 2:00 am on 1/28/2021 and finally subsided about 2:00 a.m. on 1/29/2021.
Patient experienced extreme dizziness about 36 hours after receiving shot. In addition, she stated she just didn't feel 100% all over, dizziness was somewhat better on day 4; and she was starting to feel like herself again by day 5.
IMMEDIATE Strange warmth/tingling down left arm and then further down body Dizziness  Headache Fatigue brief chills LATER & NEXT DAY Pain left arm Muscile aches, especially legs Brief episode of nausea Slight fever
tested positive for COVID; showing symptoms; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE REACTION (showing symptoms) and COVID-19 (tested positive for COVID) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-May-2021, the patient experienced ADVERSE REACTION (showing symptoms). On 06-May-2021, the patient experienced COVID-19 (tested positive for COVID). At the time of the report, ADVERSE REACTION (showing symptoms) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
legs gave out, he couldn't get up/legs still hurt. Little sore; difficult to stand up; bit dizzy; nauseous; fever/low fever but it keeps going down; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (legs gave out, he couldn't get up/legs still hurt. Little sore), DYSSTASIA (difficult to stand up), DIZZINESS (bit dizzy), NAUSEA (nauseous) and PYREXIA (fever/low fever but it keeps going down) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unk) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 04-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Mar-2021, the patient experienced PAIN IN EXTREMITY (legs gave out, he couldn't get up/legs still hurt. Little sore), DYSSTASIA (difficult to stand up), DIZZINESS (bit dizzy), NAUSEA (nauseous) and PYREXIA (fever/low fever but it keeps going down). At the time of the report, PAIN IN EXTREMITY (legs gave out, he couldn't get up/legs still hurt. Little sore), DYSSTASIA (difficult to stand up), DIZZINESS (bit dizzy), NAUSEA (nauseous) and PYREXIA (fever/low fever but it keeps going down) outcome was unknown.            Concomitant meds: a lot medications . Tx: nausea meds.
telephone call - states got covid vaccine 12-27-20 (Moderna) in L arm, did not have any sx for 3 days,  10d after developed inc redness, swelling, hot painful area 2 in below the injection site, was not itchy; did have tingling sens. in the arm, took Benadryl which reduced the tingling and swelling - now resolved
c/o pain @ site of inj (lt deltoid) that has not resolved w/use of heat & cold, & advil;states induration was present;cont above tx but pain persists;induration is almost resolved;pain is worse @ noc;
Pt received Pediarix, Prevnar + Hib vaccines on 3/29/04. Bilat thighs swollen, tender. Presented for RSV vaccine today- Aborted 2 hours to end of season.
rash; a stinging feeling under breast area that now goes around to her back.; spreading more to her back and on the side and it is stinging; This is a spontaneous report from a contactable consumer (patient). A 94-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) via an unspecified route of administration on 10Jun2021 (Batch/Lot Number: EW0187) as 2ND DOSE, SINGLE DOSE for covid-19 immunizations. The patient medical history was not reported. The patient's concomitant medications were not reported. Previously patient took first dose of BNT162B2 via an unspecified route of administration on an unspecified date (Batch/Lot Number: EW0177) for covid-19 immunizations. On an unspecified date, patient woke up today with a stinging feeling under breast area that now goes around to her back. She was unbale to see if here was a rash. The patient experienced some problems. She stated she was supposed to get the 1st one so great and that last night her body while she was sleeping maybe she woke up this morning and the stinging had spread to her back and more to the side. It was a stinging that she wanted to scratch and that she was not scratching it. Last night she thought something wasn't right. She showered this morning and thought it would go away and it was spreading more to her back and on the side and it was stinging. The stinging felt like a sting you want to scratch, not like something but you but like you have to rub or scratch it. It was like she has to scratch it and she doesn't want to as she doesn't know what will happen. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
MUSCLE TIGHTNESS ON LEFT SIDE; SORENESS IN THE OPPOSITE ARM; HEADACHE; This spontaneous report received from a patient concerned a 51 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included codeine allergy. The patient was previously treated with codeine.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A, and  expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination.  No concomitant medications were reported.  On 09-APR-2021, the subject experienced headache. On 11-APR-2021, the subject experienced soreness in the opposite arm. On 12-APR-2021, the subject experienced muscle tightness on left side. Treatment medications (dates unspecified) included: acetylsalicylic acid, and paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from headache, and muscle tightness on left side, and had not recovered from soreness in the opposite arm. This report was non-serious.
Right arm with swelling, itching and erythema about 10cm x 6.5cm.  Swelling increased over a 5 day period.
Large red swelling itchy nodule around injection site that remained there for 4 days post injection.  Headache.  Aches.  Patient took Benadryl and naproxen with some relief for headache, but no relief for swelling and itching. Day 5 the swelling disappeared.
Pt had immunization for varicella on 8/2/01 and broke out with chicken pox on 9/10/02.
No adverse effect; multiple patients were vaccinated with improperly stored VARIVAX; This spontaneous report was received from a medical assistant refers to a patient of an unknown age and gender. The patient's pertinent medical history, concurrent condition, concomitant drug and drug reactions/allergies were not reported. On 15-MAY-2019, the patient was vaccinated with 1 dose of improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (strength, dose, route was not reported) lot # r024023, expiration date of 22-AUG-2019 for prophylaxis (product storage error). Other suspect therapies included sterile diluent (strength, dose, route of administration, lot/batch# and expiry date were not reported). No adverse effects were reported. There was a previous temperature excursion and the time frame and temperature was unknown. No product quality complaint was involved. This is one of several reports received from the same reporter.
25-30 hours later woke up with shortness of breath and chest pressure in night. Next am 99.4 fever, general malaise. Next night woke up again with shortness of breath, chest pressure. Fever of 100.4 in am. Urgent care that afternoon sent me to the ER.
feeling / weak; feeling dizzy; This case was reported by a consumer via call center representative and described the occurrence of weakness in a 78-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 28th July 2021 02:00, the patient received the 1st dose of Shingrix (intramuscular). On 29th July 2021, 1 days after receiving Shingrix, the patient experienced weakness and dizziness. On an unknown date, the outcome of the weakness and dizziness were not recovered/not resolved.   It was unknown if the reporter considered the weakness and dizziness to be related to Shingrix.  Additional details provided were as follows: The reporter called to report that he received the dose of Shingrix in the right deltoid and next day he started feeling dizzy and weak. The patient was referred to health care professional. As per PI and content severe allergic reactions were less common and included hives, swelling of the face/throat, difficulty breathing, a fast heartbeat, dizziness and weakness. Reporter was encouraged to seek medical attention multiple times. Patient insisted he would wait until to see how he felt before seeking medical attention.  Reporter consented to follow-up.
Given full dose versus booster in 4th dose.  Had an old Booster vs. Additional Dose Workflow.
Noticed painful headache on Saturday 4/23/22 and thought I had a migraine. Hearing was ok in the am. By the afternoon hearing was decreasing and I thought I had an ear infection. Sunday AM I still had a headache and hearing was worse. Sound was muffled and sounded like I was hearing under water. Monday morning I called my ENT provider and had a hearing test after the ear exam came back clear. Tuesday I started on a course of Prednisone. Diagnosis of Sudden Neurosensory Hearing Loss - right ear
Pfizer-BioNTech COVID-19 Vaccine EUA.  Shingles contracted approximately one week after the first shot. I had received the Zoster (Zostavax) innoculation on 09/25/2015.