chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Myocarditis; Acute onset of chest pain; Soreness of the arm; A spontaneous report was received from a physician concerning a 20-year-old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced soreness of the arm, acute onset of chest pain, and myocarditis.   The patient's medical history, as provided by the reporter, included asthma, and allergy to egg, peanut and tree nuts. Concomitant medications reported included dupilumab, montelukast, budesonide / formoterol, cetirizine, albuterol and epinephrine.  On 29 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot number: 025J20A) intramuscularly for prophylaxis of COVID-19 infection.   On 26 Jan 2021, prior to the onset of events, the patient received their second of two planned doses of mRNA-1273 (Lot number: 028L20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.   On 26 Jan 2021, after receiving the second dose of the vaccine, the patient reported soreness of the arm for 3 to 4 days.  On 30 Jan 2021, the patient presented to the hospital with acute onset of left sided chest pain. The physician reported that the patient developed myocarditis. Consent for Safety to follow up was received.  Treatment for the events, as reported, included patient's concomitant medications of dupilumab, montelukast, budesonide / formoterol, cetirizine and albuterol. No additional treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The event, soreness of the arm, was resolved on unknown date. The event acute onset of chest pain and myocarditis was not resolved at the time of this report.; Reporter's Comments: This case concerns a 20 year old male with medical history of multiple allergies, who was hospitalized with serious unexpected events of chest pain and myocarditis and a non-serious unexpected event of pain in extremity.  The chest pain and myocarditis occurred 33 days after first dose and 4 days after last dose of mRNA-1273.  Based on the current available information and temporal association between the use of mRNA-1273 and the start date of the events, a causal relationship cannot be excluded.
Fever, vomiting, rash, body aches and myalgia. Could not walk some days. Suspected MISC
Pt recvd vax & 10 hrs p/vax exp arm numbness, chest pain & SOB; events have resolved;
Fever to 103.6 F and local redness at injection site of Dtap and influenza.
Vertigo; Dr visit due to an adverse reaction; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (Vertigo) and VACCINATION COMPLICATION (Dr visit due to an adverse reaction) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VERTIGO (Vertigo) (seriousness criterion medically significant) and VACCINATION COMPLICATION (Dr visit due to an adverse reaction) (seriousness criterion medically significant). At the time of the report, VERTIGO (Vertigo) and VACCINATION COMPLICATION (Dr visit due to an adverse reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Patient had to go to the hospital.  Treatment medication was not provided by the reporter.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
3 - 4 hours after dose ( Dose approx 1030 am reaction 2-230 pm) Light headed then dizzy blood pressure dropped to As low as 85 over 48 then appeared to have a small seizure and passed out.  He recovered before ambulance arrived and blood pressure returned to 112 over 68.   Then higher when EMT took it after arrival. Today (1day later) he has a bit of a sore neck and is still a little tired.  Blood pressure 133 over 70 which is slightly higher than is normal.
On a Saturday the fifth i started feeling tired. I went to bed that night. I woke up the next morning and my daughter was saying she was not feeling well and took a test she was positive and i took a test and was positive. I went to urgent care it was also positive. I felt like i got hit by a truck and they gave me a. the next 2 days were a blur i think i slept through most of them. And then for four and five days i started feel a lot better almost feeling better. I had a lingering stuffy nose and was losing my voice i thought it was an allergy. I went to the doctor and they said it was my lungs. They did a x ray and i had soot on my lungs it was pneumonia. 2 weeks later i went to see my doctor they gave me more meds and a steroid. Last week i started to get my voice back,
Felt fine for first 36 hours, then the typical "viral prodrome" feelings of fuzziness with a low grade temp of 99.9 and generalized malaise overnight.  Felt fine on day 3 post-injection. Starting that evening of 3/5/21 I noted sharp pains of phyarngitis (like Strep), but ONLY on the RIGHT side.  When I woke the next morning,  very painful to swallow, very tender nodes only in the Right neck that were somewhat enlarged.  The pain was strictly located to the RIGHT side of my neck and throat.  No axillary nodes or tenderness.  Today my symptoms persist - I find that I wake up after 4 hours of lying supine due to soreness in Right neck and increased fullness in soft tissues.
No additional adverse event reported; Administered PROQUAD with a temperature excursion; PROQUAD administered intramuscularly; This spontaneous report was received a health professional referring to a 4-year-old male patient. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 09-FEB-2023, the patient was vaccinated with a measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection that suffered a temperature excursion; lot #W019627, expiration date on 19-DEC-2023, administered intramuscularly in the right thigh, for prophylaxis (product storage error, incorrect route of product administration).  The temperature excursion occurred on 20-JAN-2023 through a reading of a digital data logger, which lasted one hour at a temperature range between -14°C and -10°C. No additional adverse event was reported.
Patient is a basic trainee, otherwise in excellent health.  He was immunized with MMR (second immunization, did not have protective titers to rubeola, did have + rubella titer) and Hepatitis A (negative titer prior to immunization).  He was also given prophylactic Bicillin injection as well.  Two hours after getting all three injections, patient noticed "numbness" of the lip, "difficulty controlling body" (difficulty breathing and talking and contracting hands.  Did not loss conciousness.  Did not have congestion, difficulty swallowing or throat itching, no wheezing, no nausea/abdominal cramping, no hives.  Transported to Urgent Care Center by ambulance.  Treated with steroids and antihistamines (not sure about epinephrine) and symptoms resolved.
Right Upper Shoulder pain. Swelling of Right Upper Shoulder. MRI scan conducted. Scanned revealed a rotator cuff tear. Had physical therepy and cortisol shot to help relieve pain and discomfort.
On the evening after receiving the COVID19 vaccination (May 7), I experienced severe flu-like symptoms. On May 8 these symptoms gradually disappeared, but during the night I woke and was drenched in sweat. The night sweats continued for the next four nights and then disappeared. On May 13 my wife heard a strange noise in my chest which I later identified as a heart murmur. I did not have any pain or other obvious symptoms, but I felt a slight tingling in my toes and fingers. I went to urgent care, where I was referred for an echocardiogram. The echocardiogram was performed on the morning of May 21, and endocarditis with highly mobile vegetation on the right coronary cusp leaflet of the aortic valve was identified.
joint pain; feels dizzy; weak; drowsy; slight headache; feels like a zombie; stomach is expanding and he has lost six pounds; covid blahs; This is a spontaneous report received from a contactable consumer (patient reported himself). A 73-year-old male patient received first dose of BNT162B2 (Pfizer-BioNTech Covid-19 Vaccine, Formulation: Solution for injection) via an unspecified route of administration three weeks ago on an unspecified date in Feb2021 at single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. Caller stated that he had the first Pfizer Covid 19 vaccine three weeks ago. Caller stated that he had joint pain the first day only. Caller reports that ever since he got the vaccine, he felt dizzy, weak, drowsy and has a slight headache and stated he felt like a zombie like he drank a six pack of beer the night before. Caller stated his HCP said he had the Covid blahs. Caller stated his stomach was expanding and he had lost six pounds. Caller stated that it feels like he had Covid again every morning. Caller stated he felt normal before the vaccine. Caller stated that he was afraid to get the second shot wanting to know if his reaction would be considered a contraindication and will the second dose be worse. Caller was number four in the queue and did not want to hold. AE noted. Outcome of the events was unknown. No PQC Present.  Information on the lot/batch number has been requested.
Severe headache, nose bleed, chills/low grade fever, swelling & redness site of injection, severe back ache.
she lost her hearing; Rheumatoid arthritis; problems walking; terribly dizzy; can't smell; Long Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 77-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, single), for COVID-19 Immunization, reaction(s): "diagnosed with Covid", "diagnosed with Covid"; Bnt162b2 (Dose 2, single), for COVID-19 Immunization, reaction(s): "diagnosed with Covid", "diagnosed with Covid"; Bnt162b2 (Dose 3 (booster), single), for COVID-19 Immunization, reaction(s): "diagnosed with Covid", "diagnosed with Covid"; Bnt162b2 (Dose 4 (booster), single), for COVID-19 Immunization, reaction(s): "diagnosed with Covid", "diagnosed with Covid". The following information was reported: DEAFNESS (medically significant), outcome "unknown", described as "she lost her hearing"; RHEUMATOID ARTHRITIS (medically significant), outcome "unknown"; GAIT DISTURBANCE (non-serious), outcome "unknown", described as "problems walking"; DIZZINESS (non-serious), outcome "unknown", described as "terribly dizzy"; ANOSMIA (non-serious), outcome "unknown", described as "can't smell"; POST-ACUTE COVID-19 SYNDROME (non-serious), outcome "unknown", described as "Long Covid".  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300083013 Same patient/product, different dose;
Information has been received from a nurse referring to an unspecified number of unspecified patients. On unspecified dates in 2015, since 06-AUG-2015 the patients were vaccinated with an unspecified number of improperly stored doses of (Oka-Merck) PROQUAD (lot # L007230, expiration date 03-SEP-2016) (dose and route unspecified). No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Tiredness in the day which I didn't have before getting my Covid vaccine. I had the tiredness right after getting my COVID vaccines for two weeks then got better. However, in April and May, it starts again until today. It affects my daily work a little.
pt exp agitation, tachypnea, hypoxia & HTN;pt given 02; IV was started; pt to ER; rxn was presumed to have resolved;
NAUSEA and vomiting.  Lasted until 03/30/2015 at 8:00 AM.
Child was found non responsive & with apnea 13FEB91 was taken the ER w/o successful resuscitation;
covid vaccine breakthrough  dose 1 Moderna 2/15/21 015M20A
Beginning about 12 or so hours after second shot, developed whole body rash from neck to upper legs.  Slightly itchy but more tender than anything.  This lasted for about 48 hours.  Also, both hands were swollen and extremely itchy.  This happened the first and second nights after the injection.  Benadryl helped the itching.  In addition i had fever to about 100.1  and fatigue.
PFIZER-BIONTECH COVID-19 VACCINE, BIVALENT. Patient 9 years old. Received Pfizer Bivalent booster for 12+ years old.
R thigh with possible cellulitis. Erythema, induration, warmth up to 4-5cm in length (3cm wide). Started on antibiotics (cephalexin) due to concern of infection. Improving by 9/17/19, but area still palpable on R thigh, not tender.
11/23 developed about 20 varicella lesions, fever 102 in office.  Lesions localized face, abdomen, back 1 in mouth.
states she developed sx 1/2/2022 and tested positive 1/3/2022 has had 2 doses of Pfizer- 2nd dose listed above, no booster
This spontaneous report was received from a physician assistant regarding to a patient of unknown age and gender. The patient's concurrent conditions, historical conditions and past drugs were unknown. Concomitant therapies included sterile diluent. On 23-JAN-2019 the patient was vaccinated with PROQUAD (Albumin status of rHA (recombinant human albumin)) (dose, frequency and route were unknown) (lot # N016994; expiration date: 29-NOV-2018) for prophylaxis, which was expired (expired product administered). No adverse effects (no adverse event) reported.
Woke with severe chills/trembling. All body joints sore.  Temperature 99.8. Usually 96-97. Didn?t do anything figuring it would be a temporary thing. Managed to get back to sleep after about an hour. Interrupted sleep most of the night. In the morning just felt like someone severely beat my whole body. Temperature was coming down.   Now 03/22/2021 everything is back to normal.
severe headache and very moderate amount of facial edema which required a referal to the emergency room via personal physician with treatment to include medro;-steroid dose pack, phenerga for nausea, lortab for severe headach and benadryl
Two quarter sized painful, raised, red, rough rash displayed in jagged ring one around injection site with second rash to the left of injections site decribed the same rash at injection site but has 1/2 inch by 2 inch red line running from rash towards inside of arm, difficult to raise arm for one day, continues to be painful if lays on it.  No other symptoms, no fever, no nausea, no vomiting.
Client going into nursing school, received varicella vaccine 8-4-09. On 8.15 and 16 took home pregnancy test which confirmed pregnancy. She had stopped her birth control pills 2 weeks prior vaccination due to menstrual period for entire month of July 2009. Will see Gyn/ob F.u.
This spontaneous report was received from an office manager 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 an unknown date, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 lot # R016638, expiration date 28-JAN-2020 (dose and route of administration were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of -2.94 degrees Celsius for one hour. Data logger was involved. There were multiple previous excursions below 0 degrees Celsius reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1811USA001977: US-009507513-1811USA001975: US-009507513-1811USA001858.
A Major, in Neurology Service, is referring a 31 y/o M, ADSM, SFC for vaccine causality assessment. SM developed bilateral optic neuritis after receipt of Yellow Fever vaccine. SM also reports the receipt of Rabies vaccine and either Typhoid or Influenza vaccine two days before his YF vaccine but there is no current administrative evidence to support this claim.
pt went to the ED for cough and fever; diagnosed with UTI and positive for COVID; dc'd to home; per death certificate, pt died at home due to COVID, UTI, and dementia
Got my period a week early. Very heavy flow and had it for almost two weeks when I usually only have it for 4 days with a very light flow.
Patient received Janssen COVID vaccine on 5/21/21. Patient was admitted to our facility from 9/21/21 to 9/23/21 mainly for DKA, newly diagnosed type 2 DM, acute kidney injury, and systemic inflammatory response syndrome. However, patient was found to be COVID positive on 9/21/21 with COVID pneumonia. Lung sounds were coarse in bilateral bases. CXR shows faint bilateral infiltrates. The patient has a mild intermittent dry cough, but no other COVID-19 symptoms. Requiring 2 L O2 via NC on admission, but quickly weaned off. Patient received REGEN-COV during inpatient admission.
Began about 9:30PM shaking chills, muscle aches, cold, temp 99.1. Today 11/29/21 still feeling bad, no energy, body aches and chills. Couldn't sleep. Woke up at 3:30 AM on 11/29/21, unable to sleep due to shaking chills, aches. Just don't feel good.
While waiting at the pharmacy after receiving the COVID19 vaccine at 6:17 pm , I have been called by the patient?s sister that her sister needs help. When I reached the patient was on the floor conscious, had pulse and reported no shortness of breath,  but seemed lightheaded. Customer?s mother held customer while she?s sitting on the floor , no injury reported by customer. Pharmacy associate, was asked to call 911, and to alert Management . EMS arrived and checked patient and confirmed that the patient?s vitals were good and found out from customer that she did not eat anything since yesterday. Customer stated that she was feeling good and told EMS personnel that she did not want to be taken to the hospital. After EMS had left, customer was asked to wait at the pharmacy until she felt it's safe for her to leave. At 7:09pm , customer was asked to go home along with her mother and younger sister. Customer seemed alert, conscious and mobile.
I was on a trip, I started getting a bad headache, cough and generally didn't feel well. My roommate on the trip tested positive for COVID-19 on January 28, 2023, I tested negative. I was in quarantine and was once again tested on January 30, 2023, this time it did come back positive. I was given an antiviral, antibiotic, cold medication and nasal spray.
dehydration; spent all day Saturday in bed, then slept through sat night as well; red ant pile/Blisters have turned into red dots similar looking to hand foot and mouth; hands/weists and feet and onto shins, looks like I had stuck everything in a red ant pile,also swollen; skin is still red, cracked and painful; skin is still red, cracked and painful; itchy; side effects hit like a ton of bricks; rash and small blisters all over both hands/weists and feet and onto shins; injection site pain; chills; fever; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DEHYDRATION (dehydration), SOMNOLENCE (spent all day Saturday in bed, then slept through sat night as well), ERYTHEMA (red ant pile/Blisters have turned into red dots similar looking to hand foot and mouth), PERIPHERAL SWELLING (hands/weists and feet and onto shins, looks like I had stuck everything in a red ant pile,also swollen) and SKIN FISSURES (skin is still red, cracked and painful) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    In 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced DEHYDRATION (dehydration), SOMNOLENCE (spent all day Saturday in bed, then slept through sat night as well), ERYTHEMA (red ant pile/Blisters have turned into red dots similar looking to hand foot and mouth), PERIPHERAL SWELLING (hands/weists and feet and onto shins, looks like I had stuck everything in a red ant pile,also swollen), SKIN FISSURES (skin is still red, cracked and painful), PAIN OF SKIN (skin is still red, cracked and painful), PRURITUS (itchy), VACCINATION COMPLICATION (side effects hit like a ton of bricks), RASH VESICULAR (rash and small blisters all over both hands/weists and feet and onto shins), VACCINATION SITE PAIN (injection site pain), CHILLS (chills) and PYREXIA (fever). In 2021, VACCINATION SITE PAIN (injection site pain) had resolved. At the time of the report, DEHYDRATION (dehydration), SOMNOLENCE (spent all day Saturday in bed, then slept through sat night as well), ERYTHEMA (red ant pile/Blisters have turned into red dots similar looking to hand foot and mouth), PERIPHERAL SWELLING (hands/weists and feet and onto shins, looks like I had stuck everything in a red ant pile,also swollen), SKIN FISSURES (skin is still red, cracked and painful), PAIN OF SKIN (skin is still red, cracked and painful), PRURITUS (itchy), VACCINATION COMPLICATION (side effects hit like a ton of bricks), CHILLS (chills) and PYREXIA (fever) outcome was unknown and RASH VESICULAR (rash and small blisters all over both hands/weists and feet and onto shins) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       It was reported that patient's wife and 5 month old had no similar symptoms or infections, urgent care had  prescribed a steroid cream.  No concomitant medication details were provided.
DOSE #1 WAS GIVEN OUTSIDE OUR FACILITY UNKNOWN TO US.  DOSE #2 WAS GIVEN AS DOSE #1, #3 WAS GIVEN AS DOSE #2.
I administered Havrix 1440 unit immunization to female patient. She felt fine right after the shot and left the pharmacy area. She returned about 25 minutes later feeling light headed and nauseated. I had her sit down in the IMZ booth and I took her blood pressure. Her blood pressure was slightly elevated and her pulse rate was around 100. I administered 10 mls of liquid Banophen (generic Benadyl). I continued to monitor her blood pressure, and within 15 minutes she felt normal, her blood pressure dropped back down to a normal level and her pulse rate came down to 83. She said she felt normal and was no longer light headed nor nauseated. She was able to leave the store on her own.
Diarrhea X 3.  Took Imodium 10-31-08.  Swollen, tender lymph node under left arm.  Going down now.  No fever.  Mild nausea on 11/3/08.
Fever of 100 degrees, headache, muscle aches, joint pain, nausea, fatigue. I felt like O had the flu. I had these symptoms from 4:30 pm on 3/10/21 to 7:00 am on 3/12/21.
Extreme pain right upper arm prescribed diclofenac500 75 mg stopped meds sfter 1 week pain came back on meds again , at most painful time can?t raise arm
Patient describes itching at the site of the injection that lasted for several days.  The site then became indurated, warm, and tender.