chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Within 10 minutes of receiving injection in right arm I felt a BOOM flush all over my body like I just had an IV Contrast.  Then I became dizzy, my heart started racing, I started cold sweats and felt tightness in my mid upper chest to the base of my throat.  The ED RN on site took my BP and HR and had me lie down because I felt that I couldn't breath.  She called paramedics who took my BP and HR, then did a 12 lead EKG.  They transported me to the ED.  I was worked up for cardiac, lung, chemistry.  My troponin-HS was slightly elevated and a cardiologist was called.  He did an echo on my heart, liver and right kidney -- normal.  Chest X-ray was normal.  A second 12 lead EKG was done, normal sinus.  Hematology, Chemistry was normal.  Was in the ED from 11:30 to 4:00 p.m.  Advised by ED Doctor, and Cardiologist, that it seems the stress of the anaphylaxis reaction stressed the heart which caused the spill of troponin.  Advised to see my cardiologist and get a stress test.  I have already informed my Primary Care Doctor and he has prescribed me an EPI-PEN to carry.  I have no history of allergic reactions/anaphylaxis reactions to vaccines.  I am up to date with all other vaccines and just had my yearly flu shot in November 2020.  This was my first allergic reaction/anaphylaxis reaction to a vaccine.
fainted, in and out once, lifted legs and rubbed chest and patient returned to normal in under a minute
Pt concerned that smallpox immunization and anthrax immunizations x3 In 2004 caused him to have myocarditis diagnosed in 2014. Causality assessment shows temporally unrelated. Where immunized not know. Vaccine lots not know.
Patient is a 78-year-old male with history of atrial fibrillation on Eliquis with a pacemaker, CAD, COPD with oxygen dependence on 2 L nasal cannula, CHF and recent COVID infection 9 days ago presenting to the emergency department via EMS for shortness of breath.  Per nursing staff, they went to check on patient at shift change, and they noticed he did not have his oxygen on, and he seemed to be altered.  They quickly put his oxygen back on and checked his oxygen and noted his oxygen to be 31% at that time.  They also noted patient to be hypotensive, they note with a blood pressure with a systolic in the 70s.  Upon arrival to the ED, patient does appear altered, he is alert and responsive, however he does not answer questions.  EMS placed patient on 12 L nonrebreather with an oxygen saturation in the 80s per EMS.  Upon arrival to the ED, patient's oxygen saturation is 99 to 100% on the 12 L nonrebreather.
Vaccine past beyond use date administered to a patient; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine past beyond use date administered to a patient) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine past beyond use date administered to a patient). On 10-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine past beyond use date administered to a patient) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant products were reported. No treatment information was reported by the reporter. The reporter stated that a vaccine that expired on 09-NOV-2021 12 hours after it had been punctured and at room temperature. The expired dose was administered at 8:34PM on 10NOV2021 .
This spontaneous report was received from a nurse refers to an unspecified number of patients of unknown age and gender. Medical history was not reported. The nurse informed that on an unknown date improperly stored doses of ROTATEQ oral, (strength, dosage, lot number and expiration date were not reported) oral, were administered to patients. No adverse effects were noted. This is one of several cases received from the same reporter. Additional information has been requested.
Case number PHEH2015US000677, is an initial spontaneous report from a pharmacist received on 05 Jan 2015. This report refers to an adult female patient. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN (batch number: 14554P) intramuscularly at a dose of 0.5 ml on an unknown date. The pharmacist reported that FLUVIRIN reached below 36 F for 3.5 non-consecutive days and 33.1 F for less than 12 hours. The pharmacist does not believe that the vaccine was frozen instead thinks it was thermometer malfunction. No adverse event was reported following the maladministration. No further information was provided.
seizure; This is a spontaneous report from a non-contactable consumer. A patient (the consumer's cousin) of unspecified age and gender received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced seizure and hospitalized over a week on an unspecified date. The outcome of event, seizure was unknown.  No follow-up attempts are possible; information on the lot/batch number cannot be obtained.
Vertigo; Nausea; Severe, terrible sweating; Headache; Chills; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Severe, terrible sweating), VERTIGO (Vertigo), HEADACHE (Headache), CHILLS (Chills) and NAUSEA (Nausea) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Apr-2021, the patient experienced HYPERHIDROSIS (Severe, terrible sweating), HEADACHE (Headache) and CHILLS (Chills). On an unknown date, the patient experienced VERTIGO (Vertigo) and NAUSEA (Nausea). The patient was treated with PARACETAMOL (TYLENOL) for Headache, at an unspecified dose and frequency. At the time of the report, HYPERHIDROSIS (Severe, terrible sweating), VERTIGO (Vertigo), HEADACHE (Headache), CHILLS (Chills) and NAUSEA (Nausea) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.   This case was linked to MOD-2021-106494, MOD-2021-209386 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 16-May-2021: Follow-up information received on 16-May-2021, updated reporter address. On 05-Jun-2021: Follow-up information received on 05-Jun-2021, added new events and updated outcome of the events.; Sender's Comments:  MOD-2021-106494:2nd dose case MOD-2021-209386:Same reporter (wife case)
pt recvd vax;swelling in arm, pain & redness & flu like sxs; on 12jul, 10 days later,broke out in rash; no fever; as of 6jul93 is fine, on corticosteroids & antihistamines;
This spontaneous report (initial receipt 05-Jun-2012) concerns a 15-year-old female patient, who had a medical history of type 1 diabetes mellitus and a reaction to Thimerosal in prior vaccination (type uncertain) which resulted in rash. Concomitant medication included NOVOLOG insulin via a pump. On 20-Feb-2012 the patient received INFLUENZA vaccination in her right deltoid (manufacturer and batch no. were not provided) and PNEUMOVAX 23 0.5 ml intramuscularly in her left deltoid. On 21-Feb-2012 the patient experienced left upper arm cellulitis, left arm pain and fatigue. Most of the patient's left upper outer arm became erythematous, warm and very tender. She developed a fever of 100.7F. She was treated with oral AUGMENTIN and intramuscular (IM) ROCEPHIN. The next day the redness in upper arm improved but new redness and swelling developed in her clavicle and lower arm near elbow. The fever resolved. New areas of erythema would begin in the arm as other areas resolved. AUGMENTIN was stopped and OMNICEF was started. The erythema stopped spreading. Clindamycin was provided for methicillin-resistant staphylococcal aureus (MRSA) coverage. By 29-Feb-2012 the erythema and warmth had resolved. The pain persisted for another month or so. The outcome for the events was recovered. The patient was no longer receiving treatment. On 29-May-2012, the reporter provided PNEUMOVAX 23 as a suspect drug and INFLUENZA vaccination as a concomitant medication.
Dose 3:  Pfizer-BioNTech 12/16/2021 , irregular heart beat 4-6 weeks. 01/16/2022 Contacted the physician remotely and was asked to go to hospital for heart monitor and monitored heart activity for two weeks.  Not on medication but they states that she had 7 episode of irregular heart beat over two weeks and they are monitoring it.
28mm red, swollen, hot and tender to touch. (L) side numbness and tingling.
Child given Moderna vaccine dose for ages 6 months for 5 years ands would have been given Pfizer 5-11 year old vaccine.
The Pt presents with syncope 45 minutes post 1st dose Pfizer to the left deltoid. The Pt was first evaluated 5 minutes post vaccination at 16:47 for anxiety and dizziness. At that time he was given 2 juice boxes and his symptoms resolved. The pt was waiting with his partner another 30 minutes when he stated that he once again began to feel nausea, extreme anxiety, and had +LOC while seated for a few seconds. Pt had no head trauma or other injury. He noted that he had only eaten an acai bowl today at 11AM, slept poorly last night, has not been keeping well hydrated, and has been feeling anxious leading up to getting the vaccine. He has a Hx of anxiety but is currently not on any medications. He denies allergies. Pt denies swelling of the face, throat tightness, difficulty swallowing, itching of the skin, SOB, or CP.
Right arm: Painful; Swollen axilla lymph nodes; tender lymph node; Severe Pain at elbow; This is a spontaneous report from a contactable nurse (Patient). A 34-year-old non-pregnant female patient received first dose of bnt162b2 ((PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number: EL0140), via an unspecified route of administration in right arm on 21Dec2020 09:45 at single dose for covid-19 immunization in hospital. The patient's medical history was not reported and there was no known allergies. The patient's concomitant medications were not reported. There was no other vaccine in four weeks. The patient experienced right arm painful, swollen axilla lymph nodes, tender lymph node and severe pain at elbow on 26Dec2020. The events was non-serious. Th events result in Doctor or other healthcare professional office/clinic visit. There was no treatment. The outcome of the events was unknown.  Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hadn't been tested for COVID-19.
EDC 10/22/18, Dime sized reddened area that continued to spread. Warm and firm to touch.
Started getting a red itchy bumps on front of neck and was itchy, went to the doctor and was prescribed cream Desonide twice daily and it went away on neck. A few weeks later the bumps returned on elbows and shins, responded to cream and went away, but still periodically it returns. She treats it with Gold bond Eczema relief and it relieves it periodically, but then it still always returns at different parts of her body.
This spontaneous report was received from a medical assistant and 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 19-JUN-2017 the patient was vaccinated with improperly stored PEDVAXHIB (dosage and route not reported), lot # M032149, expiration date 18-APR-2019 for prophylaxis. There was no adverse effect reported. Temperature: 47 degrees Fahrenheit to 77 degrees Fahrenheit for1 hour. A digital data logger was involved. Previous temperature excursion: 47 degrees Fahrenheit to 77 degrees Fahrenheit for 2 hours. Additional information has been requested.
I have a 16 month old daughter and am 15 weeks pregnant with my second, due date July 2, 2021. I noticed today redness and swelling at the injection site after showering, slightly itchy when touched
Screaming episode 6P-10PM 28NOV90; 6P-10PM 29NOV90; 6P-10PM 30NOV90; Temp 103.
Terribly  painful  left arm at injection site.  Headache, chills, tired, diarrhea.
Acute onset chest pain, pain with breathing x 6 days at this point. Denies fever or cough.  EKG normal. CBC, CHest XR ordered. IBU 400mg TID until symptoms resolve.
The patient was administered the first dose of the Moderna COVID-19 vaccine. Immediately after the injection, the patient lost consciousness in his seat and slumped over. He was caught by the pharmacist, then briefly seized before regaining consciousness. Upon regaining consciousness, the patient complained of feeling hot and dizzy. Emergency medical services were called and they arrived within 5 minutes. In that time, the patient appeared to have mostly recovered and was comfortable leaving after being cleared by EMS. The patient was referred to their physician for guidance regarding the second dose of the vaccine.
Toungue became dark purple that night.  During the weekend it was painful to eat food.  Mother called 10/26/2010 to ask if this was something to be concerned about, but it was getting better.  Did not call the doctor.
Per mother patient has bumps to face and thighs. Did telehealth for patient was sent Triamcinolone and Cetirizine to pharmacy.
REDNESS, SWELLING, ITCHINESS, SIZE OF REACTION IS 3-3.5 INCHES IN DIAMETER.  HE CALLED HIS PCP AND WAS TOLD TO COME BACK TO THE PHARMACY FOR INSPECTION. HE WILL APPLY ICE AND HYDROCORTISONE CREAM IF THE ICE DOES NOT STOP THE ITCHING REACTION.
HEADACHE; This spontaneous report was received from a  female patient of an unspecified age, reporting on herself. The patient's weight was 150 pounds, and height was not reported. No past medical history or concurrent conditions were reported. The patient received Covid-19 vaccine AD26.COV2.S (suspension for injection, intramuscular, batch number: 1805022 expiry: 25-MAY-2021) dose was not reported, administered on 04-MAR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported.  On 04-MAR-2021, the subject experienced a headache. It was reported that the subject called to ask if she can take TYLENOL (paracetamol) for her headache after receiving the Janssen Covid-19 vaccine, about 4.5 hours ago (it was unspecified if paracetamol was taken).  Action taken with Covid-19 vaccine AD26.COV2.S was not applicable. The patient had not recovered from headache. The reported considered the causality between the headache and Covid-19 vaccine AD26.COV2.S as related. This report was non-serious.
Dizziness.  Woke up morning after and the room was moving around me.  This dizziness continued off and on for several days.  I thought it had passed and woke up today 3/29/2021 to the same dizziness and very soar ribs.  Slight headache off and on.
I had no real rection to the first 4 shots. Just a little soreness in the arm for a couple of days. I had the 5 short at the same time and in the same artm as the flu short. No pain at all for 2-3 days. I now have significant pain: sometimes in the shoulder, sometimes halfway between the shoulder and the elbow. Sometimes dull, sometimes sharp. Pain only comes when I hold or move my arm in certain positions and particularly when i try to lift something relatively heavy.
chalky taste in my mouth; bad breath; stuffy and thus breathing issues; This is a spontaneous report received from a contactable Consumer reporting for herself.     A 61-years-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 23Mar2021 13:45 (Batch/Lot Number: EP6955) as single dose for Covid-19 immunisation  .  The patient medical history and concomitant medications were not reported.  The patient experienced chalky taste in my mouth on 29Mar2021 with outcome of not recovered , bad breath  on 29Mar2021 with outcome of not recovered , stuffy and thus breathing issues  on 29Mar2021 with outcome of not recovered.    No follow-up attempts are needed. No further information is expected.
A tingling feeling at tip of nose and over both lips of my mouth, also outside edges of my tongue; A tingling feeling at tip of nose and over both lips of my mouth, also outside edges of my tongue; This is a spontaneous report from a contactable consumer, the patient. A 74-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 09Feb2021 at 11:30 (at the age of 74-years-old) as a single dose for COVID-19 immunisation. Medical history included Type 2 diabetes, high blood pressure, obesity, essential tremor, IBS-D (irritable bowel syndrome), RBBB (chronic), sleep apnea, allergy to penicillin and sulfa. Concomitant medications included amlodipine besylate (MANUFACTURER UNKNOWN); levothyroxine (MANUFACTURER UNKNOWN); metformin (MANUFACTURER UNKNOWN) and pioglitazone hydrochloride (PIO). The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 09Feb2021 12:00, about 30 minutes after injection received, the patient got a tingling feeling at tip of nose and over both lips of my mouth, also outside edges of my tongue. This lasted about 12 hours. The patient did not receive any treatment for the events. The outcome of the events was recovered on an unknown date in Feb2021.  Information on the Batch/Lot number has been requested.
PT WAS VACCINATED SEVERAL MONTHS AGO, PRESENTED TO ER WITH C/O CP AND SOB 8/22, NEG ANGIOGRAM COMPLETED 8/23, DC HOME 8/23 RETURNED TO ER 8/24 WITH LARGE SADDLE PE, PT EXPIRED. ONLY REPORTING BECAUSE PT HAD NO PRIOR HISTORY OF MI OR THROMBOSIS, ONLY HTN AND TYPE 2 DM.
she had headache every morning; and is very tired; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (she had headache every morning) and FATIGUE (and is very tired) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019M20A or 014M20A) for COVID-19 vaccination.     No Medical History information was reported.  The patient's past medical history included Chickenpox. Concomitant products included DICLOFENAC for an unknown indication.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (she had headache every morning) and FATIGUE (and is very tired). At the time of the report, HEADACHE (she had headache every morning) and FATIGUE (and is very tired) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No treatment information was provided by the reporter   This case was linked to MOD-2021-288281 (Patient Link).
pt appeared to hold breath @ time of inject; lost consciousness for about 15 seconds; pt became very pale & diaphoretic; heart rate fluctuated from a very rapid to slow rate;
heat in injection arm; redness on the injection arm; swelling on the injection arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (heat in injection arm), VACCINATION SITE ERYTHEMA (redness on the injection arm) and VACCINATION SITE SWELLING (swelling on the injection arm) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high and Diabetes.    On 26-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 VACCINATION SITE WARMTH (heat in injection arm), VACCINATION SITE ERYTHEMA (redness on the injection arm) and VACCINATION SITE SWELLING (swelling on the injection arm). At the time of the report, VACCINATION SITE WARMTH (heat in injection arm), VACCINATION SITE ERYTHEMA (redness on the injection arm) and VACCINATION SITE SWELLING (swelling on the injection arm) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient's concomitant medications included unspecified high blood pressure and diabetes medication.   No treatment information was provided.
All of a sudden the caller's arm was not getting better, the caller's arm was getting worse; Felt sick for a few days; That arm was a little sore; The caller woke up and felt like really bad like the flu; Everything on the caller ached the callers little finger nails and joints; The caller wanted to do things and tried to get up and do something but had no energy; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 75-years-old female patient received bnt162b2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Batch/Lot Number: EW0202), via intramuscular in left arm on 01Jun2021 at 11:00 as 1st dose, single for COVID-19 immunization (75 years at the time of vaccination). Medical history included ongoing lyme disease for a bout 20 years now. The patient was tested positive for COVID-19 on an unknown date in Dec2020 to an unknown date. The patient had double pneumonia from an unknown date and the patient recovered from this. The patient had flu shot and never had any problems with the flu shot. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 01Jun2021, post vaccination the patient experienced arm was a little sore, all of a sudden the patient's arm was not getting better, the patient's arm was getting worse. The patient was not able to put her arm behind her back. The patient stated the arm soreness woke the patient up in the night. On 02Jun2021, patient felt sick for a few days. On an unspecified date in Jun2021, the patient woke up and felt like really bad like the flu. Everything on the patient ached, little fingernails and joints. Everything was aching, the patient felt blah like the flu. The patient wanted to do things and tried to get up and do something but had no energy. The patient had to lay back down. The patient stated that this lasted 4 days. The patient tried to do something and had no energy, was weak and just wiped out like the patient had the flu. When the patient had Covid (back in Dec2020) and was in the hospital with Covid, the doctor told the patient to remember that the Covid symptoms can linger for quite a few months. The patient stated that she could still have effects. Patient thought maybe because she had Covid, is she was still having effects after. The patient had to visit the doctor due to the events. The doctor checked the patient and said the arm wasn't red and the arm looked a little swollen and told the patient to keep a check on the arm. The patient had reported that the second dose for the vaccination has been scheduled on 22Jun2021 and the patient was concerned about if she should take it or not. Outcome of felt sick for a few days was recovered on 06Jun2021, arm was a little sore was not recovered while for the other events was unknown.   Information on lot/batch number was available. Additional information has been requested.