chrisvoncsefalvay/vaers-outcomes huggingface dataset:
About an hour after felt very off, like something shooting through my body and them difficulty taking a breath. It happened again that evening when trying to eat dinner.  Had a low fever and intense arm pain.  The next day the difficulty breathing happened again, heart rate very elevated, eating started to become stressful because starting to have a choking feeling along with sudden intense of difficulty breathing, another night with a fever and arm intently sensitive, couldn't even let cloning touch it. The next several days arm became hotter and hotter and blotchy. Fever went away the constant high heart heart and trouble slowing breathing down continued along with eating getting more and more difficult. That following Monday had a dentist appointment and Blood Presser was higher then it's every been recorded for me.  I"m normal 120/70 this was I believe 138 over 80. Friday 4/9 went to see Primary Care doctor, first time seeing her, diagnosed with bacteria infection from the vaccine. arm was still burning hot and the raised heart beat, trouble breathing and eating were getting worse. From there everyone got worse. I believe I was in the ER 7 times over the next 3 months, I lost about 25 pounds in 5 weeks.  It kept changing, at my worst I couldn't exert any energy and breathing was so difficult.  I spend most nights in a chair could only sleep 10 to 20 minute before I would wake up with arms and head tingling and trying to breath. By mid June I'd had so many test and not answers, the doctors just kept prescribing different anxiety medications which seemed to make things worse and Prilosec. By the end of June I could tell things were changing by so slowly.  No on month 7 I still have at least 5 more pounds to gain, it's still difficult eating large portions and I still can't walk at a normal rate with my family without my throat tightening up and having to stop to catch my breath. I'm hopeful that even though it's very slow going someday I will recover, be able to eat a normal diet again and go back to being who I was.  A wife and mom who loved getting my family outdoors and an upbeat person.
03-27-10 Quarter size redness to back of left arm.  03-29-10 Redness to back of arm & warm & tender.
Pt developed strong daily headaches.  She reports a history of sever headaches in her past history.  She noticed daily headaches after 1st Gardasil vaccine.  The headaches subsequently subsided.  She reports recurrence of headaches within days of 2nd Gardasil vaccine
Received Dtap and IPV on 8/24/06. Came into clinic 8/26/06 c/o redness, swelling and tenderness at site.
administered only the adjuvant; administered only the adjuvant; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 3rd November 2021, the patient received Shingrix. On 3rd November 2021, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The patient administered with only the adjuvant of Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter had no demographic information of the patient and believed patient was vaccinated the day before reporting date, but was not sure. The reporter consented to follow up.
Where I got the shot is still red and itchy. This has been there since I received the injection. I am unsure if it?s from the vaccine or a reaction to the band aid.
SOB, cough, congestion, headache, sore throat, loss of taste, loss of smell, chills.        Patient denies diarrhea, body aches, fever. starting around 10/22/21
pt exp diff breathing, dizziness & tightness in the throat 1wk post vax;pt also taking med for malarial prophylaxis;pt went to MD 6JUL96 & had blood test done;MD indicated poss side effects to malarial drug;
Fully vaccinated and tested positive for COVID.; Fully vaccinated and tested positive for COVID.; This is a spontaneous report from a contactable consumer or other non-HCP (patient). A patient of unspecified age and gender received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EP6955) via an unspecified route of administration on 23Mar2021 as dose 1, single and received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EP6955) via an unspecified route of administration on 13Apr2021 as dose 2, single for COVID-19 immunization. Patient medical history and concomitant medications were not reported. The patient experienced fully vaccinated and tested positive for covid on an unspecified date in 2021.  Event took place after use of product. The patient underwent lab tests and procedures which included sars-cov-2 test positive on an unspecified date in 2021. The outcome of event COVID-19 was unknown.
Body aches, chills, joint pain, fatigue, and severe migraine for 72 hours. Only thing taken for symptoms was Tylenol 500mg as needed.
I started having chills and loss of energy.  The second day really felt very tired.  When I took my blood pressure it was very high.  Twice in the next few days I went to the ER with over 200 over 79  I saw my family doctor and they did a  k g and said my heart was out of rhythm and they sent me to the cardiologist.  I still feel light headed and blood pressure still high and heart rate low.
severe sciatic nerve pain; uncontrolled hypertension; L leg pain; L arm pain; lymph node pain; lymph node numbness; This spontaneous case was reported by a pharmacist and describes the occurrence of SCIATICA (severe sciatic nerve pain), HYPERTENSION (uncontrolled hypertension), PAIN IN EXTREMITY (L leg pain), PAIN IN EXTREMITY (L arm pain) and LYMPH NODE PAIN (lymph node pain) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included IBUPROFEN, METFORMIN, HYDROCHLOROTHIAZIDE, OLMESARTAN MEDOXOMIL (OLMESARTAN/HYDROCHLOROTHIAZIDE) and INSULIN GLARGINE for an unknown indication.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, the patient experienced SCIATICA (severe sciatic nerve pain), HYPERTENSION (uncontrolled hypertension), PAIN IN EXTREMITY (L leg pain), PAIN IN EXTREMITY (L arm pain), LYMPH NODE PAIN (lymph node pain) and HYPOAESTHESIA (lymph node numbness). The patient was treated with HYDRALAZINE ongoing from 14-Mar-2021 for Adverse event, at an unspecified dose and frequency; MORPHINE ongoing from 14-Mar-2021 for Adverse event, at an unspecified dose and frequency and ONDANSETRON (ZOFRAN [ONDANSETRON]) ongoing from 14-Mar-2021 at an unspecified dose and frequency. On 17-Mar-2021, SCIATICA (severe sciatic nerve pain), LYMPH NODE PAIN (lymph node pain) and HYPOAESTHESIA (lymph node numbness) had resolved. At the time of the report, HYPERTENSION (uncontrolled hypertension), PAIN IN EXTREMITY (L leg pain) and PAIN IN EXTREMITY (L arm pain) outcome was unknown.        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.   Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: Additional initial On 26-Jun-2021: F/U-2 : Hospital records; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship is unlikely.
cried over 3 hrs persistantly p/last immun 11OCT94 had swelling & redness @ the site of inject;
Severe visual aura/disturbance similar to severe migraine, followed by immediate disappearance of symptoms
Breakthrough case after Covid vaccination. Dose #1 2/25/2021 Dose #2 04/01/2021. Asymptomatic.
She was experiencing palpitations/Discomfort in her chest; This spontaneous case was reported by a pharmacist and describes the occurrence of ATRIAL FIBRILLATION (She was experiencing palpitations/Discomfort in her chest) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036C21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19. Concomitant products included LOSARTAN, DRONEDARONE HYDROCHLORIDE (MULTAQ) and APIXABAN (ELIQUIS) for an unknown indication.  On 07-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jun-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ATRIAL FIBRILLATION (She was experiencing palpitations/Discomfort in her chest) (seriousness criterion medically significant). The patient was treated with CARVEDILOL for Adverse event, at an unspecified dose and frequency. In August 2021, ATRIAL FIBRILLATION (She was experiencing palpitations/Discomfort in her chest) had resolved.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered ATRIAL FIBRILLATION (She was experiencing palpitations/Discomfort in her chest) to be possibly related.    Company Comment - This spontaneous case concerns a 51-year-old, female patient with no relevant medical history, who experienced the unexpected, serious AESI of atrial fibrillation. The event occurred approximately 2 hours after administration of the first dose of the Moderna mRNA-1273. The patient presented with chest discomfort and palpitations, and was brought to the emergency room department where she was diagnosed with atrial fibrillation. No information was provided regarding laboratory test/s done. The patient was given fluids and was started on carvedilol. After 2 months, the event resolved. The rechallenge was not applicable as the event occurred after the first dose. The benefit-risk relationship of the Moderna mRNA-1273 is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 15-Nov-2021: Significant Follow Up information included Event added/ Patient details added.; Sender's Comments: This spontaneous case concerns a 51-year-old, female patient with no relevant medical history, who experienced the unexpected, serious AESI of atrial fibrillation. The event occurred approximately 2 hours after administration of the first dose of the Moderna mRNA-1273. The patient presented with chest discomfort and palpitations, and was brought to the emergency room department where she was diagnosed with atrial fibrillation. No information was provided regarding laboratory test/s done. The patient was given fluids and was started on carvedilol. After 2 months, the event resolved. The rechallenge was not applicable as the event occurred after the first dose. The benefit-risk relationship of the Moderna mRNA-1273 is not affected by this report.
Janssen COVID-19 Vaccine EUA.  About 8.5-9hrs after receiving the vaccine, I started getting body aches in my legs and hips. I started getting really cold, took my temperature and it was at 100.1. Got a headache, slightly nauseous, body aches got a lot worse (particularly my lower back). I was also feeling a little dizzy and having a hard time comprehending information; this was probably the fever. Around 8pm,  I took my temperature again and it had risen to 102. I took some extra strength Tylenol which started helping about 30 minutes later. I woke up 3/12/2021 still with some body aches, slight headache, and slight stomachache.
24MAR94 awakened during noc w/chills, fever, body aches, temple h/a; 25AUG93 MD chills, fever, sore throat gone; still has heavy breathing-?flu;
Pain in spine, numbness and tingling, back pain, tinnitus, weakness in arms and legs. It has been over 8 weeks since the vaccine, and still have tinnitus and weakness in arms and legs.
Red rash with itchy skin and stiff, painful muscle on injection site. Benadryl and hydrocortisone 1% was given has a treatment.
Severe stomach pains; Vomiting; This spontaneous case was reported by a patient and describes the occurrence of ABDOMINAL PAIN UPPER (Severe stomach pains) and VOMITING (Vomiting) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     Concomitant products included GABAPENTIN, QUETIAPINE FUMARATE (SEROQUEL), LEVETIRACETAM, SYNODRIN, LAMOTRIGINE (LAMICTAL) and AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL) for an unknown indication.    On 25-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1. On 26-May-2021, the patient experienced ABDOMINAL PAIN UPPER (Severe stomach pains) and VOMITING (Vomiting). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, ABDOMINAL PAIN UPPER (Severe stomach pains) and VOMITING (Vomiting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Concomitant medication includes supplements.
Pt recv vax on 8/31/98; on 9/1/98 pt exp welts on upper body, stomach, back, upper arms & face w/ itching; tx=Benadryl
Second degree AV block, Mobitz type II-s/p PPM placement. ED visit and hospital admission within 6 weeks of receiving the COVID vaccine.
swelling of lymph nodes; surrounding tissue (big lump) on shoulder near collarbone only on the side of the injection; This is a spontaneous report from a contactable consumer (patient). A 39-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: Ep7534, patient was not pregnant at the time of vaccination), via an unspecified route of administration, administered in Arm Left on 23Mar2021 05:00 AM (at the age of 39-year-old) as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history was not reported. Concomitant medication(s) included sertraline hydrochloride (ZOLOFT) taken for an unspecified indication, start and stop date were not reported and Birth control (Unspecified) both received in two weeks. No other vaccine received in four weeks. No Covid prior vaccination, no Covid tested post vaccination. On 14Apr2021 at 07:00, the patient experienced swelling of lymph nodes, surrounding tissue (big lump) on shoulder near collarbone only on the side of the injection. It was reported that event occurred with the first shot days later. No treatment was received for events. The outcomes of events were unknown.  No follow up attempts are possible. No further information is expected. .
really sick for 30 hours; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (really sick for 30 hours) in a male patient of an unknown age 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 ILLNESS (really sick for 30 hours). At the time of the report, ILLNESS (really sick for 30 hours) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications was provided by the reporter.  No Treatment medications was provided by the reporter.    This case was linked to MOD-2021-210459 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 07-Jun-2021: Source Doc(additional) added
Patient developed eight hematoma on the left lower leg starting on day 5 or 6 after the initial injection. These are tender to the touch. Pt  contacted the office on 4/13/2021. Pt was sent to a testing facility for a venous doppler study which came back negative for a DVT of the left lower extremity. These were consistent with hyperechoic 1 cm proximal and distal calf, consistent with hematoma. Pt had miltiple areas of bruising seen in the lower extremity. Pt told to apply warm heat to the site and take  EC-ASA  81 mg po daily.
He had body aches; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (He had body aches) in a 20-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Sep-2021, the patient 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Oct-2021, the patient experienced MYALGIA (He had body aches). At the time of the report, MYALGIA (He had body aches) outcome was unknown.            No concomitant medications were not reported. No treatment medications were not provided.   This case was linked to MOD-2021-344206 (Patient Link).
It was reported in a published article that a patient with a history of familial cellular immunodeficiency was vaccinated with a dose of MMR. Subsequently, the patient developed necrotizing measles lymphadenitis. Upon internal review, necrotizing measles lymphadenitis was considered to be an important medical event. Additional information has been requested. It was also reported that a second patient developed autism after being treated with MMR.
On 1/15/02, the pt received 2 shots on her pediatric visit. On 1/28/02, she began running a low-grade temperature of 99-102F daily. On 2/13/02, her fever went to 103F and nothing could break the fever. (Cold compresses or a cool bath). Pediatrician advised to give Tylenol 15 minutes before her seizure. At 16:00 on 2/13/02, her temperature rose to 104F and she lapsed into a seizure. We called 911 and they transported her to the hospital. Her seizure lasted 13-15 minutes. In the ER, she went into a post-ictal state, which lasted for over 1/2 hour. She was given Ativan to control the seizure activity. Post seizure paralysis remained until 2/15/02 and she was very unstable in her gait and abilities. She was discharged on 2/15/02. On 3/3/02, she was fine all day. She ate, played and acted normal. She took a nap at 14:30 and woke up at 14:50 with a 103F temperature (Ax). She was given Tylenol and Motrin at 14:55 and put her in a tub to cool down. The seizure started at 15:05, called 911 and they transported her immediately at 15:10 and administered a prescribed 50mg of Diastat and her respirations slowed. The seizure lasted 13 minutes; ER stabilized her and moved her to PICU. PICU attending ordered and performed a spinal tap, which was negative. 6/25/02 Hospital discharge summary states child had episodes of vomiting and slight cough prior to onset of seizure and developed a rash while in hospital after being started on Amoxicillin for possible OM.
Cellulitis at injection site treated with Keflex, ibuprofen (varicella).
A 15-year-old female patient had received a left arm, intramuscular injection of Menactra, lot number U2371AA; a right arm, intramuscular injection of Adacel, lot number C2775AA; and a left arm, intramuscular injection of Human Papilloma Virus Vaccine, manufacturer Merck, lot number 1424F; on 03 January 2008. The next day, the patient developed a 1.5 inch lump at the left axilla without redness or pain. No treatment was provided. At the time of this report, the patient had not recovered.
Please see continuation page. He had hives on neck, legs 1 hour after receiving vaccines yesterday Gave benadryl, but then he felt his throat was closing Hives spread throughout diffusely his entire body Mom gave him hydrocortisone cream and hives subsequently went away for the next few hours He slept and didn't complain of any throat issues overnight, this morning, feels a lot better Denies any throat closure, able to swallow just fine, no respiratory distress, no cough, no labored breathing, no GI sx (no nausea, vomiting, diarhea), no neuro sx (no syncope, no lightheadedness, no headache, no feeling faint), feels perfectly fine. Hives are completely gone this morning and feels no symptoms.   Denies fever, chills, sweats, denies conjunctival injection, eye issues, earache, ear pain, nasal discharge, neck pain, SOB, cough, cyanosis, nausea, vomiting, diarrhea, arthalgia, urinary symptoms, headache, abnormal movements or rash.   Told mom anaphylaxis can be biphasic and the second occurrence can happen anytime from 1-72 hours, he should be carefully monitored, epi pen prescribed to pharmacy and spent 5 min counseling on appropriate use and administration, if recurrence - epi pen needs to be used and go straight to ER. Mom to pick up Epi Pen. Discussed only new vaccine he received was Men B#1, will put on allergy list and told mom we can pursue testing - will mail out referral. ER criteria spoke about in detail.
got the full 0.5 ml instead of the booster dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL OVERDOSE (got the full 0.5 ml instead of the booster dose) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ACCIDENTAL OVERDOSE (got the full 0.5 ml instead of the booster dose). At the time of the report, ACCIDENTAL OVERDOSE (got the full 0.5 ml instead of the booster dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications was not reported.  Treatment medications was not reported.  This is a case of Accidental Overdose concerning a patient of an unknown age and gender with no relevant medical history, who experienced no other adverse events. The event occurred the same day after receiving the third dose number of mRNA-1273 Vaccine. The rechallenge was not applicable since only information about the third dose was disclosed. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This is a case of Accidental Overdose concerning a patient of an unknown age and gender with no relevant medical history, who experienced no other adverse events. The event occurred the same day after receiving the third dose number of mRNA-1273 Vaccine. The rechallenge was not applicable since only information about the third dose was disclosed. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Patient described body aches, muscle cramps with back pain. Febrile with chills. No nausea, no vomiting or headache. Lasted for 12 hrs.