chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Arm was very sore when waking up , 9/10 pain and weakness. Tylenol was taken and dulled. Range of Motion extremely  limited for days to follow- continued taking Motrin. Extremely limited foor days to follow continued taking tylenol for pain. Pian is less, and now more rom, but still having difficulty with arm, In addition to arm, sweats, chills, aches, fever 102.1  Follow up with PCP ruled out DVT. Got RX for muscle relaxers, but not filled but felt better over weekend. Will go get medication filled and start
dizziness, body ache, slight headache, weakness, sore arm, and just tired. Drink lots of water, and sleep. Symptom started around 6am the following day after the vaccine. Started with sore arm, then weakness and tiredness. Later body ache, dizziness and slight headache.
PAIN/EXCRUCIATING; DID NOT SLEEP; SORE TO TOUCH; HARDLY MOVE ARM; 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 past medical history included bad shoulder, and concurrent conditions included spinal stenosis, and psoriatic arthritis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced pain/excruciating. On APR-2021, the subject experienced did not sleep. On APR-2021, the subject experienced sore to touch. On APR-2021, the subject experienced hardly move arm. Treatment medications included: ibuprofen, and paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pain/excruciating, sore to touch, and hardly move arm, and the outcome of did not sleep was not reported. This report was non-serious.
Heart attack/sharp pain in my chest; breathing problems; sweeling; This is a spontaneous report from a contactable consumer or other non-HCP (patient) via Medical Information Team. A patient of an unspecified age and gender received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration on 19May2021 as dose 1, single for COVID-19 immunization. Patient medical history and concomitant medications were not reported. Patient did Pfizer vaccine on 19May2021 and three days after first dose did have like heart attack, sharp pain in chest breathing problem swelling on 22May2021. Went to emergency room. The outcome of the events was unknown.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Moderate nausea, loss of appetite & mild fever with chills - all expected.    Unusual/ Adverse effect was a significant change in heart rhythm.  Patient is consistently in A-Fib post PaceMaker insertion (June 2020). He is paced at 70 bpm when in A-Fib.  His hearth rhythm went into sinus ~2.5 days post vaccine, and has remained so since.  Change is quite unusual and has only occurred once since pacemaker insertion (October 2020) when he had a significant flu/cold event.   More relevant is the increase in systolic blood pressure by over 20 pts.
9-15-16 bad headache-took Ibuprofen. 9-17-16 left arm started with lump and swelling and itch really bad. Took BENADRYL pills and a gel on skin. Did not work. Few day later blister came up. 9-26-16 6 blisters, swelling went my legs. Took Ibuprofen and put CALADRYL on and help. Oct. 9 it going away.
severe anaphylaxis; This is a spontaneous report from a non-contactable Consumer. This Consumer reported similar event for six patient. This is 6th of sixth reports.   A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not reported), via an unspecified route of administration on an unspecified date a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced severe anaphylaxis on an unspecified date with outcome of unknown.  No follow-up attempts are possible. Information about batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021003207 same drug/event and different patients
A physician reported that an infant revceived Acel-Imune vaccine and subsequently developed a nodule at the injection site. MANUFACTURERS COMMENT: The reporter indicated that 2 pt's experienced this event; however, they are not presently identifiable. An additional report will be generated when identifying information is provided.
This spontaneous report was received from a pharmacist refers to a patient of unknown age. The patient was inadvertently vaccinated an expired dose of ZOSTAVAX (lot # 671659/1255AA, expired date 01-NOV-2012) (dose not reported) subcutaneously on 11-NOV-2012. No adverse effect reported. Additional information has been requested.
Shortly after vaccination, patient complained of tongue and lip swelling, broke out in hives on her chest, and began having trouble breathing. Patient was evaluated by EMS, BP & HR elevated, O2 stats stable. EMS administered 50mg Benadryl without improvement. EMS then administered Epinephrine 0.5mg. Pt also placed on VM with 2.5mg Albuterol. Pt began to improve. EMS administered 125mg Solumedrol and transported pt to ED for further evaluation.
mom states pt had fever 102 on 6NOV92 p/shots; fever cont to rise & got to 105 on SAT AM; pt called MD & was told to cont w/APAP & was seen by MD on SUN AM; states MD feels reaction was from DTP;
Flushed, tingling in hands and feet,  GI upset,  BP elevation - symptoms continue one week later
103.5 fever, chills, sweats for 36 hours; not back to normal for 48-72 hours
Patient called today complaining that she woke up with a sore throat. It is not serious and is not intending to seek medical care at this time.
Severe tinnitus: Two days after receiving my first dose of the Pfizer Covid19 vaccine, the pre-existing tinnitus in my left ear, which has been stable and very mild for 35+ years, suddenly spiked to an almost unbearable level. It has remained consistently high ever since. New tinnitus symptoms presented in my right ear at the same time. I also experienced a sudden decline in my hearing acuity. I additionally experienced tingling and muscle weakness in my face, which has since resolved. However the severe tinnitus remains.
Small ruptured capillary immediately after injection. Seen by Dr. He said blood pressure was fine, no issues breathing. Patient told him she has issues with platelets. He said just small hematoma from injection.
ACUTE PULMONARY EMBOLISM 12/20/2022  &  1/4/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
[after previous doses] swelling; [after previous doses] pain at the injection site/[after previous doses] soreness; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING ([after previous doses] swelling) and VACCINATION SITE PAIN ([after previous doses] pain at the injection site/[after previous doses] soreness) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016M20A and 012L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SWELLING ([after previous doses] swelling) and VACCINATION SITE PAIN ([after previous doses] pain at the injection site/[after previous doses] soreness). At the time of the report, SWELLING ([after previous doses] swelling) outcome was unknown and VACCINATION SITE PAIN ([after previous doses] pain at the injection site/[after previous doses] soreness) had resolved.            No concomitant medication information was provided. No treatment information was provided.   This case was linked to MOD-2022-647145, MOD-2021-015968 (Patient Link).
sever nausea within 24 hours, lasting 4 or more days (currently on going) Most noticeable in the a.m. and last evenings. Tiredness first day after vaccine, ceased after that. Headache first post 2 days.
soreness in his arm; pain happens when he tries to lift his arms above shoulder level; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soreness in his arm) and PAIN (pain happens when he tries to lift his arms above shoulder level) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included POTASSIUM CHLORIDE, LISINOPRIL, CHLORTHALIDONE and PARACETAMOL (TYLENOL) for an unknown indication.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced PAIN IN EXTREMITY (soreness in his arm) and PAIN (pain happens when he tries to lift his arms above shoulder level). At the time of the report, PAIN IN EXTREMITY (soreness in his arm) and PAIN (pain happens when he tries to lift his arms above shoulder level) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment related information was reported.
This spontaneous report as received from a nurse refers to a 4 years old male patient. The patient was vaccinated with (Merck) VARIVAX (Lot# reported as H007704, dose/frequency, route and duration were unspecified) on an unknown date. Subsequently the patient experienced inflammation and swelling at the injection site on an unknown date. The location of where injection on the body was unspecified by the reporter. No treatment information was reported. The outcome was unknown. This is one of several reports received from the same source. Additional information is not expected.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 08-AUG-2016, the patient was vaccinated with an improperly stored dose of VARIVAX lot # L026410, expiration date 15-FEB-2017 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccine experienced a temperature excursion of 4 degrees Celsius for 75 hours. Data logger was involved. Additional information has been requested.
The pt experienced redness, swelling from shoulder to fingers (about twice its normal size). This started approximately 1 day post vax lasting several days. Treated with hydrocortisone cream and elevation.
This spontaneous report was received from a medical assistant and refers to a 7 month old patient of unknown gender. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On 11-FEB-2016, the patient was vaccinated with an improperly stored dose of ROTATEQ, orally, lot # L013202, expiration date: 27-JAN-2017, (dose was not reported). According to the reporter, the vaccines were stored at a temperature of 50.2 degrees Fahrenheit for 9 hours and the temperature excursion took place due to unit adjustment with the door open for stock counting. There was no previous temperature excursion reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
VARIVAX given on 2/25 in patient's right arm. On 3/6, parents noticed a 5-8 mm induration with surrounding erythema. On 3/7 it became larger and a second smaller papule appeared above it.
Heart palpitations daily and frequently occurred very recently after the second dose. I began having mild chest pain approx. 2 months after, progressive to intermittently moderately several times weekly, has now progressed to daily mild to moderate L sided chest pain, with  one episode of severe on 7/27/21. The mild to moderate pain has continued almost constantly since then.
I was awakened with severe chills and body aches during the night. I had severe pain when I tried to just roll over in bed and also when I got up to walk. I stayed home from work the next day. I took some Ibuprofen and rested that entire day.  On 1/22/2021, I woke up in the morning with a red rash on my neck as well as some patches of a red rash on my abdomen. I also had an enlarged lymph node on the left side of my neck. I contacted my doctor who  told me to take some Benadryl which I did that night. The rash then faded a couple days later, and the swollen lymph node resolved within a week or so. I did remain quite fatigued for a few weeks following my vaccination.
Pt presented for generalized weakness, altered mental status, severe diarrhea. Determined COVID positive on 2/14/2021. Patient was found to have elevated CPKs severe hyponatremia bilateral groundglass opacities on CT scan and mild colitis.  Patient was given hypertonic saline and admitted to intensive care unit where she was placed on mechanical ventilation. Patient currently still admitted.
Pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 Vaccination.     Concurrent medical conditions included Migraine. Concomitant products included OLANZAPINE (OLAFID), 1 mg aspirine, progesterone injections and PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE] for an unknown indication.    On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 11-Sep-2020 and the estimated date of delivery was 18-Jun-2021. On 30-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twentieth week of the pregnancy.  At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In October 2020, Pregnancy test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Headache, Myalgia, Felt like skin was in fire, back, neck and arms, fever, chills and diaphoresis  Narrative:
11 cm x 7 cm area of erythema w/o induration surrounding injection site.
Tested positive COVID-19 two months after dose 5. Went to doctor and was prescribed PAXLOVID.
acute appendicitis less than 24 hours later. Went to ER on Saturday, January 15, 2022 less than 24 hours after receiving covid booster. Was diagnosed with appendicitis and had surgery on Sunday, January 16, 2022.
1 day after shot 1: dizziness, earache, nausea, fever, bad headache. Continued for 10 days, days 5 onward short of breath upon exercise. After shot 2: 5 days of mild fever, tiredness. Starting  2.5 weeks post shot 2: Severe debilitating vertigo and disequilibrium and reduced hearing resulting in continuous vomiting for 36 hours and an Urgent Care visit. With OTC nasal sprays, antihistamines, decongestants, Dramamine, 5 days of tiny improvements. 2 days off the OTC meds worsening the vertigo and disequilibrium. I've never had earaches nor episodes of vertigo or disequilibrium before. I'm day 7 since this started, and I still can't drive or walk straight. It's very bad.
This spontaneous report as received from a physician refers to unspecified female patients of unknown ages. On an unknown date, the patients were vaccinated with doses of GARDASIL (rouse and lot # not reported). The physician reported that on an unspecified dates, the patients experienced passing out in parking lot after receiving GARDASIL. At the time of the report, the patients' outcome was unknown. Additional information has been requested.
Two weeks following the first COVID vaccination I awoke with Sudden Onset Hearing Loss in my right ear. No prior hearing loss, no other symptoms. No other changes in health prior to the hearing loss.. Hearing loss confirmed by audiologist on 3/23/21.
COVID-19; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (COVID-19) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Ibuprofen). Concomitant products included FEXOFENADINE from 01-Apr-2022 to an unknown date for an unknown indication.    On 11-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID-19). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19, at an unspecified dose and frequency. At the time of the report, COVID-19 (COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-May-2022, SARS-CoV-2 test: positive (Positive) Positive test result. In May 2022, SARS-CoV-2 test: negative (Negative) negative rapid antigen tests between finishing Paxlovid and Positive test result and positive (Positive) Postitive test on Rapid Antigen 6 days after completion of the 5-day course of Paxlovid.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that patient took treatment of COVID-19 from 03-May-2022 to 07-May-2022 with Paxlovid.It was reported that patient experirnced postitive test on rapid antigen 6 days after completion of the 5-day course of Paxlovid and 5 consecutive negative rapid antigen tests between finishing Paxlovid and Positive test result. On 13-May-2022 the outcome was reported as recovering/resolving. was reported that along with the treatment drug patient took FEXOFENADINE of unknown medicinal product name from  01-Apr-2022 to May-2022.  COMPANY COMMENT: This is a spontaneous case concerning a 30 -years-old male patient, with no relevant medical history, who experienced unexpected non serious AESI event of covid-19, which occurred 183 days after third dose of mRNA-1273 vaccine. SARS-CoV-2 test is positive on 13-May-2022. Current ongoing pandemia remains as a confounder. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report; Sender's Comments: This is a spontaneous case concerning a 30 -years-old male patient, with no relevant medical history, who experienced unexpected non serious AESI event of covid-19, which occurred 183 days after third dose of mRNA-1273 vaccine. SARS-CoV-2 test is positive on 13-May-2022. Current ongoing pandemia remains as a confounder. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.
Started with shoulder pain, then in the night I had pain in my forearm down into my wrist and hand that led to tingling in my fingers
devel a rash w/itching;entire lt arm & lt arm axilla pit area affected;sx devel approx 6-7hr p/vax;rash lasted 12-24hr;pt took hydroxyzine HCL tablet 1hr p/ discovered rash to stop the itching;itching stopped 1-2hr later, rash remained;
Itchy, red, and warm rash, about the size of a large orange, on the left arm at the injection site of the 2nd dose on 2-8-2021.  Symptoms continued until Sunday, 2-24-21, when itching stopped.  Redness and warmth continue, but they are diminishing as of today, 2-15-2021.
ACUTE NON ST ELEVATION MI 12/27/2021  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Vestibular migraine; Dizziness; Lack of concentration; Irritability; Anxiety; Depression; Tearfulness; Nausea; Fatigue; Headache; Started to feel ill; Blurred vision in both eyes; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Started to feel ill), VISION BLURRED (Blurred vision in both eyes), VESTIBULAR MIGRAINE (Vestibular migraine), DIZZINESS (Dizziness) and DISTURBANCE IN ATTENTION (Lack of concentration) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028C20A and 001A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LORAZEPAM, SERTRALINE and PARACETAMOL, TRAMADOL HYDROCHLORIDE (TRACEDOL).   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In August 2021, the patient experienced ILLNESS (Started to feel ill), VISION BLURRED (Blurred vision in both eyes) and HEADACHE (Headache). On an unknown date, the patient experienced VESTIBULAR MIGRAINE (Vestibular migraine), DIZZINESS (Dizziness), DISTURBANCE IN ATTENTION (Lack of concentration), IRRITABILITY (Irritability), ANXIETY (Anxiety), DEPRESSION (Depression), TEARFULNESS (Tearfulness), NAUSEA (Nausea) and FATIGUE (Fatigue). At the time of the report, ILLNESS (Started to feel ill), VISION BLURRED (Blurred vision in both eyes), VESTIBULAR MIGRAINE (Vestibular migraine), DIZZINESS (Dizziness), DISTURBANCE IN ATTENTION (Lack of concentration), IRRITABILITY (Irritability), ANXIETY (Anxiety), DEPRESSION (Depression), TEARFULNESS (Tearfulness), NAUSEA (Nausea), FATIGUE (Fatigue) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Magnetic resonance imaging: ms spine MRI ruled out MS.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
hives started on elbows saturday afternoon. When he woke up Sunday his feet, elbows, knees and hands were covered with hives. Started taking Benadryl Q6hr, seen by pediatrian. Had Covid and strep test both negative. Sunday afternoon hives on ears, neck and face.
not getting any Covid nothing, always negative; " I got 2 shot I feel like I have Covid "; This is a spontaneous report from a contactable nurse  (patient).  A patient of unspecified age and gender received BNT162B2, via an unspecified route of administration in Dec2020 as single dose for COVID -19 immunization. The patient had  already received two doses.   The patient's medical history and concomitant medications were not reported.  The patient reported not getting any COVID nothing, always negative; " I got 2 shot I feel like I have COVID " on an unspecified date.  The patient underwent lab tests and procedures which included negative COVID; the patient indicated that it was always negative.  The outcome of not getting any COVID nothing, always negative; " I got 2 shot I feel like I have COVID " was unknown.   The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
No adverse reactions or events.  Rotateq was given by mistake and patient was out of recommended age range for vaccine.
3cm X 4cm red, swollen and tender area on right upper outer thigh and slight rash around the area. Treat with warm compresses and Motrin.
3 inch red reaction: red, swollen, hot, feverish, tired.  Used ice packs, Benadryl as needed.
sneezing & runny nose, watery eyes & swollen eyes, chest pain, SOB;
Pt hsopitalized on approx 2NOV92 for difficulty in breathing & asthma like sx; 5NOV92 pt devel flu like sx, nausea, dizziness, weakness, loss of appetite, loose stools, light fever & fatigue;