chrisvoncsefalvay/vaers-outcomes huggingface dataset:
swollen lymph node in injection arm; pinkness at injection site; warm to the touch at injection site; HEADACHE; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (HEADACHE), ARTHRALGIA (swollen lymph node in injection arm), INJECTION SITE ERYTHEMA (pinkness at injection site) and INJECTION SITE WARMTH (warm to the touch at injection site) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     Concomitant products included LEVETIRACETAM (KEPPRA), CARBAMAZEPINE (TEGRETOL) and PANTOPRAZOLE for an unknown indication.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced HEADACHE (HEADACHE). On 27-Jan-2021, the patient experienced ARTHRALGIA (swollen lymph node in injection arm), INJECTION SITE ERYTHEMA (pinkness at injection site) and INJECTION SITE WARMTH (warm to the touch at injection site). On 23-Jan-2021, HEADACHE (HEADACHE) had resolved. At the time of the report, ARTHRALGIA (swollen lymph node in injection arm), INJECTION SITE ERYTHEMA (pinkness at injection site) and INJECTION SITE WARMTH (warm to the touch at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details Included advil on 22 Jan 2021 for headache   Reporter did not allow further contact
Information has been received from a pharmacy student concerning a female patient who on an unspecified date was vaccinated with a dose of PNEUMOVAX 23. Subsequently, on an unspecified date the patient experienced an allergic reaction and got sick. It was not an anaphylactic reaction. It was unknown if the patient sought medical attention. At the time of the report, the patient had recovered. Additional information has been requested.
Information has been received for the Merck Pregnancy Registry for GARDASIL vaccine from a Nurse Practitioner concerning a 15 year old female with allergy to CECLOR who on 11-AUG-2008 was vaccinated with first dose of GARDASIL vaccine (Lot # not provided), 0.5ml. intramuscularly in deltoid. Concomitant therapy included hormonal contraceptives (unspecified). On 12-DEC-2008 she received second dose of GARDASIL vaccine (Lot # 659962/1740U) 0.5ml, intramuscularly in deltoid and she was pregnant. Her last menstrual period was 16-NOV-2008 and her estimated due date is 22-AUG-2009 and the day of conception was believed to be on 29-NOV-2008. There were laboratory Diagnostic Studies performed: urine pregnancy test positive. The patient sought medical attention in the office. Additional information has been received from Advance Practice Nurse (also reported as Family Nurse Practitioner) who reported that the patient received first dose of GARDASIL vaccine (Lot # not provided), 0.5ml, intramuscularly in left deltoid on 05-AUG-2008. Concomitant therapy included hormonal contraceptives (unspecified) and vitamins (unspecified). Follow up information has been received from the nurse practitioner who indicated that the patient delivered a 2 lb baby boy on 26-MAY-2009 (WAES# 0812USA03338B1). Upon internal review, premature labor was considered an other important medical event. Additional information has been requested.
patient developed diffused hives 12 hours after her vaccination/Hives; This is a spontaneous report from a contactable physician. A 56-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN5318 and expiration date was not reported), via an unspecified route of administration on 03Feb2021 as single dose for covid-19 immunization. Medical history included diabetes mellitus and hypertension. Concomitant medication(s) included metformin (METFORMIN); estradiol (ESTRADIOL) and escitalopram oxalate (LEXAPRO). The patient should take the second dose of the Pfizer COVID-19 vaccine considering that her patient developed diffused hives 12 hours after her vaccination on 04Feb2021. She said that she wouldn't categorize it as anaphylaxis. Her reaction lasted until Day 3 after the vaccination. The outcome of event was recovered.   Follow-up (10Feb2021): New Information received from the contactable consumer includes updated events and questions regarding events.
8 days later appearance of a large raised red area on site of injection that grew larger over the course of several days. Spot was very hot, itchy and painful and patient advised had muscle/join aches in legs and a migraine. Went to patient first and was diagnosed with cellulitis of the injection site.
Itching, numb tongue and throat within hour after vaccine. Diarrhea within two hours. Rash on cheeks three days later.
71 year old male patient recived the Moderna vaccine on 12/28/2020 and 1/27/2021. Tested positive for Covd-19 on 2/1/2021 (aysmptomatic).  Passed away on 2/23/2021.  Report came from facility.
This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), PYREXIA (fever (temp 101.4)), NAUSEA (nauseous) and HEADACHE (very bad headache and it "knocked me down") in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (she had Covid "pretty bad" at the end of October for 6 weeks) in October 2020. Concomitant products included CITALOPRAM, ALENDRONIC ACID and NAPROXEN for an unknown indication.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, the patient experienced CHILLS (chills), PYREXIA (fever (temp 101.4)), NAUSEA (nauseous) and HEADACHE (very bad headache and it "knocked me down"). On 03-Mar-2021, CHILLS (chills), PYREXIA (fever (temp 101.4)), NAUSEA (nauseous) and HEADACHE (very bad headache and it "knocked me down") had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Mar-2021, Pyrexia: temp101.4.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.
Systemic: pt stopped her after getting his shot at 2596 as he felt off-Mild, Additional Details: I had him sit, gave him water, his color was good, no signs of issue, he stated he does suffer from anxiety and though he might be swollen, he did not have any apparent throat swelling, he sat for about 20 more minutes and left.  I called him 2 hours later and he said he felt good and really felt it was an anxiety attack.  He appreciated me calling.  I called  at 2596 (PM) and was going to call him as well.
2 days after injection, pt. complained of welts/rash on arm where injection occurred. Still complaining today of arm being so sore. She can't lie on it. Rash/welts still present.
Pain in right side of lower jaw behind last tooth. Gland swollen on right side of neck. No sure if this is caused by vaccine or something else is going on.
pt awoke during the noc w/itching & hives & devel swollen feet;pt sought medical advice from pvt MD;DPH given per pt;
Patient given  2nd dose of Pfizer  Covid 19 vaccine, felt fine immediately afterwards, sat down to wait 15 minutes afterwards. Approximately 5 minutes later began to reportedly feel anxious, lightheaded, nauseous, sweaty, pale, and vomited. Patient alert & oriented, applied cool compress to forehead and neck, states hadn't eaten much all day, blood sugar checked =99, BP 70/51, P 62 R 16, feet elevated on chair, EMS called. BP recheck 141/114 P 74 R 16 . Patient states on Vitamin D OTC, Birth control pill, and thyroid medication. Patient stated usually gets vaccines with mom present and this was first time she got vaccine on her own. Remained alert & oriented when transported out of store via ambulance.  Called patient  at 5:55 pm to check on her, states felt much better after laying down on ambulance stretcher  when in parking lot , father called & picked her up and took her home after being released by EMS. Only complains of mild headache at present otherwise states feels well and resting comfortably at home.
Patient came to pharmacy after 24 hrs of vaccination complaining of throbbing pain on left side from head through left arm, shoulder, chest pain. his blood pressure was normal 120/73. Complained of dizziness and soreness on the left arm. Referred him to check with his doctor. Patient was reluctant to call office. Took aspirin after couple hrs of this pain, he feels little better now than before, still with some throbbing pain.
No adverse reaction to report.  Patient obtained a complete moderna COVID19 series after receiving Janssen from another provider.
Redness, warmth and induration surrounding the injection stie on the right upper thigh. No pain. No gait/limp. Given Cephalexin.
5 year old received routine vaccines on 03/01/2005. She had DTaP and IPV in left arm and MMR in right arm. Evening of vacciations pt had warmth and swelling locally to arms 03/02/2005 pt was examined and noted warm, erythema, local reaction at one site of left upper arm and a 1 1/2cm ecchymosis at second site of left upper arm. 03/03/2005 pt returned to office with a 9x9cm warm tender erythematous left arm and ecchymosis was unchanged. Patient was started on Keflex antibiotics for cellullitis.
Fever 102 degrees; muscle aches (legs back); Sore arm; This is a spontaneous report from a contactable consumer, the patient. A 13-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 06Jul2021 at 10:00 (at the age of 13-year-old) as a single dose for COVID-19 immunisation.  Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had no known allergies to medications, food or other products. The patient did not take any concomitant medication. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 15Jun2021 at 16:30 (at the age of 13-year-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 06Jul2021 at 21:00, the patient experienced fever, muscle aches (legs back) and sore arm, these symptoms lasted for approximately 24 hours. On 06Jul2021, the body temperature was reported as 102 degrees. The events did not result in doctor or other healthcare professional office/clinic visit/ emergency visit. Therapeutic measure was taken as a result of events and included treatment with acetaminophen.  Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fever 102 degrees, muscle aches (legs back) and sore arm was resolved on 07Jul2021.  The lot number for BNT162b2 was not provided and will be requested during follow up.
2-23-02 Mom noticed babe being lethargic and sleeping a lot more than usual. Sunday -skin was pale and then broke out in hives, Mom made report on 03-02-2002. Dr. notified. Hives were fading so just observed at that time.
Around 4:00 am on Sunday morning i was awaken from sleep with extreme pounding in my chest.  Was having a hard time getting a full breath. I drove to the ER near my house and when I got there I managed to get into the ER reception room and almost passed out. I could not fill out the forms as i was having trouble  seeing and controlling my hands. They took me into the room and hooked me up to the machines. They gave me some nitro  pills and a Heparin shot. They told me I was having a massive heart attack and could not do anything for me. So they transferred me to the Heart Institute for more care.  I had told them i had the second vaccine shot and the ER doctor told me it could cause these types of adverse effects. I asked him to put that in writing in my file and he refused, stating it would cost him his job and get the hospital in trouble.   When i got to the Heart Institute they again hooked me up to the machines and gave me more nitro and i think another shot of heprin. They then took me and installed a stent. i was relaesed from the hospitol on Tuesday and had another heart attack on Thursday and went back into the hospitol. call  me for more details.
pt recv vax 15MAY97 & 18AMY97 pt devel cold sx, including stuffy nose & sore throat;
Chills and uncontrollable shaking at 12:30 AM on 11/23.  By 2:30 AM, I was experiencing irregular heartbeat, two short, sharp chest pains, and racing heart.  At 4:00 AM, went to Emergency Room.  Diagnosed with Palpitation and Symptomatic PVCs after EKG and cardiovascular monitoring.  Doctor stated possibly brought on by fever (my normal temperature is 97.7, my temperature peaked at 100.1 degrees).  Was given 1 gram of Tylenol and discharged around 8:45 AM.  Tylenol reduced fever and palpitations stopped.  Fever returned around 3:30 PM, as did heart palpitations.  Took Tylenol again, reduced fever and palpitations stopped. Have never had palpitations before, even with fever.  This is the first time I have ever experienced PVCs.
Breakthrough admission after 2 vaccines Moderna 2/5/21 Lot# 010M20A;  Moderna 3/6/21 Lot# 027L20A
Patient received 1st dose 31 hours after puncture; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received 1st dose 31 hours after puncture) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 078C2A) for COVID-19 vaccination.     Concurrent medical conditions included GERD since 17-May-2021 and Hypotension since 17-May-2021. Concomitant products included OMEPRAZOLE from 17-May-2021 to an unknown date for GERD, BENAZEPRIL from 17-May-2021 to an unknown date for Hypotension.    On 14-Jul-2021 at 2:42 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received 1st dose 31 hours after puncture). On 14-Jul-2021, EXPIRED PRODUCT ADMINISTERED (Patient received 1st dose 31 hours after puncture) 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 did not provide any causality assessments.   Treatment medication were not reported.   Most recent FOLLOW-UP information incorporated above includes: On 19-Aug-2021: Patient Race and ethnicity added, Concomitant medications updated, Medical history updated, facility details and Reporter details.
Itching, primarily head, back, ears, underside of wrists; a few small hives on the undersides for wrists
tachypnea, legtharic, 99.2 low grade fever, patient usually on 2L of oxygen and had to be increase to 3L, difficulty swallowing, felt better the next day, COVID + at one point.
ACUTE NON ST ELEVATION MI  9/23/2022 -- RECURRENCE OF SAME SYMPTOMS
Left eyelid droopiness/?swelling; over the next few days, pt developed a right sided Bell's palsy 11/10/2009 MD records from 10/29/2009 ov. Patient with c/o's rt eye irritation and droopiness, lopsided smile. DX Bell's palsy. RX'd eye gtts, prednisone and Acyclovir. F/up 1 week.
Reactive arthritis of right ankle. No fever or rash. Duration of about 2 weeks. No other joints affected.
Medical assistant gave a 12 month PROQUAD and MMR II simultaneously; This spontaneous report was received from a registered nurse and refers to a 12-month-old patient. No information regarding the patient's medical history, concurrent conditions, concomitant medications, drug reactions or allergies was provided.  On an unknown date, the medical assistant gave the patient vaccination with the measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) simultaneously with the measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (dose, strength, route of administration, anatomical location, lot # and expiration dates were not reported for both vaccines), for prophylaxis (inappropriate schedule of vaccine administered).
lightheadedness; shortness of breath; tightness in the chest; This is a spontaneous report from a contactable consumer. A 83-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) dose 1 via an unspecified route of administration on 05Apr2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation . The patient medical history was not reported.  The patient's concomitant medications were not reported. The patient previously being allergic to "a lot of antibiotics", cortisone, and prednisone. She also reports that she "cannot take the flu shot because then I get the flu". Because of her medical history, she consulted with all of her HCPs and they all told her it was safe to get the Covid19 vaccine. patient received her first dose of the Pfizer-Biontech Covid19 vaccine on 05Apr2021. She has since been experiencing lightheadedness, shortness of breath, and tightness in the chest in Apr2021. She tested negative for Covid19 illness this past Sunday (11Apr2021), and her cardiologist ruled out any heart conditions as the cause. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
The night after I received the vaccine, I started to have chills, body aches and soreness in my right arm. As the night went on it progressively got worse, and I developed shortness of breath. I tried to use my inhaler and I got some relief, but I started to cough so bad that it was painful. Over the next couple of days I was extremely fatigued and could barely walk on my own. I was taken into the emergency room on 4/25/2022. The ER doctor gave me two rounds of a respiratory treatment and prednisone.
I had a high fever, I took a home COVID-19 that came back negative. I felt awful so my wife and I decided to go to the emergency room. Once in the emergency room they ran a PCR COVID-19 test that came back positive and ran a urinalysis test that came back positive for a UTI.  My sugar dropped down while I was in the hospital to 32 and 33. I was given antibiotics to get rid of the UTI and they gave me glucose and ice cream to get my glucose numbers. I was sent home once my glucose levels were up to safe levels. I am currently taking medication for a possible staph infection that I may have gotten while in the hospital.
pt recv vax 14OCT97 & 19OCT97 pt devel a rash all over body & a fever;MD reported that he did not evaluate the pt;
patient diagnosed with covid on 2.18.2021 and died of covid 3.6.2021
developed altered mental status with large left MCA territory infarction, required hemicraniectomy
Loud crackling noise in both knee joints when getting up or sitting down. No pain, no swelling or redness.
No patients experienced any adverse effects; Improperly stored dose of ROTATEQ; This spontaneous report was received from a physician concerning a patient of unknown age and gender. No information was provided regarding the patient's pertinent medical history, concomitant medications, or drug reactions/allergies.     On 19-MAY-2020, the patient was vaccinated with an improperly stored dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) vial (product storage error), by oral route (lot # 1660693, has been verified to be a valid lot number; expiration date 19-MAR-2021) as prophylaxis (dosage schedule and strength were not reported).   The administered dose of the vaccine experienced a multiple temperature excursions below highest temperature above 47 Fahrenheit degrees  to 66.6 Fahrenheit degrees for 2 hours and lowest temperature below 36 Fahrenheit degrees to 33.6 Fahrenheit degrees  for 45 minutes as recorded by a data logger. There was no previous temperature excursion. There was no adverse effect reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2006USA001703:
Patient in office for well child check, due for Meningococcal Conjugate vaccine, second dose.   Was given Haemophilus b Conjugate vaccine.  No adverse reactions.
Severe Headache and elevated heart rate starting the evening after vaccination and lasting for about 24 hours.
On the day the meningitis vaccine was administered, my son had insomnia. The insomnia went on for about 5 days. On day 6, I noticed slight personality changes. My son had crying outbursts and severe fatigue. On day 7, I noticed my son was in and out of reality and delusional. The insomnia continued throughout these days. A few days later, my son collapsed at a restroom and urinated on himself. He was taken to the ER. A few days after that, the delusional thinking, insomnia, and extreme fatigue continued. A few days after that, my son started convulsing, having what looked like seizures, and his throat was closing up. He was taken to the ER by an ambulance.
This spontaneous report as received from a nurse concerning unknown number of female patients of unknown age was vaccinated with IM, 0.5 ml GARDASIL on month 0,2,6. The nurse reported that syncope occurs more in girls than boys. The patients sought unspecified medical attention. This is one of several reports received from the same source. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available.
Approximately ~4 minutes after immunization, pt fainted as he was walking to purchase water to drink. (Pt was instructed by immunizing pharmacist to take a seat for 15 minutes after immunization). When immunizing pharmacist reached the patient, patient was already sitting up straight on a chair and drinking water from a water bottle. Pharmacist asked if patient was experiencing any symptoms of anaphylactic shock, i.e. difficulty breathing, rashes/hives, and/or swelling. Patient denied having any of those symptoms. Immunizing pharmacist had oral benadryl and epinephrine pen ready in case they needed to be administered. At the end of observation, pt felt strong enough to get up and walk. Pt was instructed by immunizing pharmacist to seek medical attention ASAP if he started to experience any symptoms of anaphylactic shock. No epinephrine or oral benadryl was administered to patient during the incident. No 911 was called either.
This spontaneous report as received from registered nurse refers to unspecified number of patients. No information regarding current condition, medical history or drug allergies were reported. On an unknown date the unspecified number of patients were vaccinated with improperly stored VAQTA (strength, dose unit, lot number and frequency unknown) for routine vaccination. No concomitant therapy was reported. No adverse effect was reported. The outcome of event was unknown. No further adverse event information was provided. This is one of several reports received from the same source. Additional information has been requested.
The day after my second shot, I noticed that my eyes felt very sore. But it seemingly resolved. However, two days later, I had severe photosensitivity.
02/14 Became ill, fever, vomiting, rash crusted dark lesions. 02/15 went to hospital. Spinal tap performed. Transferred to another facility and dx with meningococcal meningitis. Spinal fluid non reactive to antigen. Rash purpuric at this time. Discharged 02/22/2000
Dark discoloration of area below the injection. Approximately 4 x 3 inches in size descending from injection site.  Approximately 10 days after shot the effected skin area became rough/dry in texture.  As of today (day 17) the area has reduced in size to about 2.5 to 1.5 inches and appears to be fading.   The area was sore just a few days  after shot as prior injections were.  area never was itchy.  First and second shots did not do this.
Pt devel t105 & sz; taken to Hosp then transfer to another Hosp ICU; Hospitalized 10-14 days; pt had known sz disorder & had been recently weaned off PB;