chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Episode of nausea; Right-sided preauricular and superficial cervical lymphadenopathy; This is a spontaneous report from a contactable physician (patient herself).  This 36-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EJ1685), via an unspecified route of administration, at single dose on 19Dec2020 at 08:45 AM for COVID-19 immunisation. Vaccine location was left arm.  The patient was vaccinated at hospital, age at vaccination was 36-year-old. No other vaccine was received in four weeks. The patient was not pregnant. The patient did not have a relevant medical history. Relevant concomitant medications included ibuprofen and 20 Ethinyl Estradiol-3 Drospirenone. On 21Dec2020, the patient developed right-sided preauricular and superficial cervical lymphadenopathy. On 22Dec2020, the patient had an episode of nausea. The patient did not perform COVID test before and after vaccination. No therapeutic measures were taken as result of the events. The outcome of the events was unknown.
Whole body hives for one day, no wheezing or SOB, days later hives wax and wane, managing with steroids and antihistamines
Patient states she feels "like I was hit by a Mack Truck." Severe body aches and headaches began within 8 hours of vaccine administration. Additionally, edema in both calves appeared at the same time and had not yet resolved at the time of reporting adverse effects. The body aches and headaches dissipated within 48 hours. Patient made an appointment with her PCP about the edema, who prescribed furosemide 40mg daily, to be used until resolution of edema.
My lymphnodes under my arms became very swollen; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (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: Covid-19 vaccine (Primary immunization series completed, Manufacturer: Unknown), for COVID-19 immunization. The following information was reported: LYMPHADENOPATHY (non-serious), outcome "unknown", described as "My lymphnodes under my arms became very swollen".  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.
7 days after injection, patient developed painful red lesions, erythema multiforme on both hands, palm and back and interproxinal.  No lesions on feet or mouth.
On May 14 I received the covid vaccine. On June 18 I started to experience persistent diarrhea  which has continued to this date. I rarely experience diarrhea and when I do it usually lasts only 1-3 days. So on June 25 I contacted my primary care NP who ordered blood and stool labs. the diarrhea was watery, no cramping, no unusual odor or visible blood in the stool. the labs however reported trace blood in the stool. The frequency of stool was 1-2 times daily. I followed the diet suggested by my NP .Have there been any similar reports like mine regarding the J&J vaccine? Please contact me by email.
Initially thought ringworm, for which I applied topical ointment prescribed by a Physician Assistant for but it did not get better and then my primary doctor informed me it was likely pityriasis rosea and that it would go away. It lingered until the second dose which was on 1/23/2021 but did not resolve and only got worse after the second dose, the rash finally resolved 3 weeks following the second dose.
Patient remained seated after vaccination about 20 -30 seconds later she fell to the ground unconscious. Patient was still breathing and remained unconscious for 30 seconds. 911 was called but patient refused ambulance. She bumped her head on the way down and felt nauseous afterward. She had not eaten all day. So she then ate some cookies, crackers w/peanut butter and water. Monitored at pharmacy for 30 min.
patient stated that they got red on the face, ears and chest and took some Benadryl immediately afterwards which countered the effects
a female patient received a 0.5ml dose of Flublok instead of Fluzone/No AE; a female patient received a 0.5ml dose of Flublok instead of Fluzone/No AE; Initial information received on 24-Oct-2019 regarding an unsolicited valid non-serious case received from a consumer.  This case is linked to case 2019SA297880 (same reporter).  This case involves an eight years old female patient who received a 0.5ml dose INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] lot number not reported via intramuscular route in the left arm on 21-Oct-2019 instead of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error due to Inappropriate age at vaccine administration and wrong vaccine administered.  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Dose received 3/dose number = 3; I had a fever about 102 degrees; Felt absolutely terrible/could not get out of bed; Also started having bad tinnitus that lasted a few months; I had a really bad headache; Was completely exhausted; Couldnt stay awake; Had the chills; Diarrhea; This is a spontaneous report from a non-contactable consumer, the patient. A 32-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the left arm on 09Apr2021 (at the age of 32-years-old) and third (booster) dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 05Nov2021 at 17:30 (at the age of 32-years-old), both as single doses for COVID-19 immunisation. Medical history included tinnitus and flu. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER2613) via an unspecified route of administration in the right arm on 19Mar2021 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. On 09Apr2021, immediately after the second shot, the patient started having bad tinnitus that lasted a few months. The patient reported that he had tinnitus earlier in his life, about 15 years before this, but hadn't had it since. On 10Apr2021, the day after his second shot the patient had fever, about 102 degrees, felt absolutely terrible. On an unknown date in 2021, the patient could not get out of bed, had a really bad headache, was completely exhausted and couldn't stay awake, the patient also experienced chills and diarrhea and the patient felt worse than he did when he had the flu a couple of years ago. It was reported that after his booster shot (3rd dose), the patient experienced exact same way all over again. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events fever, felt absolutely terrible, could not get out of bed, really bad headache, was completely exhausted and couldn't stay awake, chills, diarrhea and tinnitus was resolved on an unknown date in 2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Severe uncontrolable shivering, fever, severe headache, 103 temperature, complete loss of appetite, loss of enengy
Received TD Wednesday, 6-15-05.  On Thursday, 6-16-05, awakened in AM with nausea and lack of appetite.  He consumed only fluids on Thursday.  Evaluated by physician on Friday:  nausea, dizziness, diarrhea, and loss of appetite.  States liver enzymes were elevated.  He states that on Monday his liver enzymes were decreased from Friday.  The nausea, diarrhea, and dizziness continued through Wednesday, when they decreased and were gone by the evening.
headache; Body ache; chills; chest pain; joint pain; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache), MYALGIA (Body ache), CHILLS (chills), CHEST PAIN (chest pain) and ARTHRALGIA (joint pain) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 20-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage form. On 21-Feb-2021, the patient experienced HEADACHE (headache), MYALGIA (Body ache), CHILLS (chills), CHEST PAIN (chest pain), ARTHRALGIA (joint pain) and NAUSEA (Nausea). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency and NAPROXEN (MOTRIN [NAPROXEN]) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, HEADACHE (headache), MYALGIA (Body ache), CHILLS (chills), CHEST PAIN (chest pain), ARTHRALGIA (joint pain) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant Medications were not provided by the reporter.
18 x 30 mm reddened hard area (L) upper thigh x 9 days.
COVID 19 Treatment/ first positive test; COVID 19 Treatment/ first positive test; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05Apr2021 as dose 1, single (Batch/Lot number: unknown), in right arm, on 27Apr2021 as dose 2, single (Batch/Lot number: unknown), in right arm, on 15Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown), in right arm and on 12May2022 as dose 4 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "acid refulx" (unspecified if ongoing); "Allergy:penicillin" (unspecified if ongoing). Concomitant medication(s) included: VAGIFEM, start date: Dec2009 and also reported as patient took other medication in 2weeks. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 19Jun2022 at 21:00, outcome "not recovered" and all described as "COVID 19 Treatment/ first positive test". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: 12 days after my first positive test, and 7 days after my last dose of Paxlovid, I tested positive for Covid. I have rebound Covid. Therapeutic measures were taken as a result of vaccination failure, covid-19 included Paxlovid (lot number: 980227470407) started on 09Jun2022 and stopped on 12Jun2022. No treatment received for symptoms and patient was not recovered from symptoms.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
2/18/21. Received vaccine.  2/19/21 (24 hrs.) - Sore arm, fever to 100.5F.  2/20/21 (36 hrs.) - onset headache, neckache, muscle aches shoulders, back, upper arms.  2/20-2/24. Worsening of severe headache, neck stiffness and muscle pains. (score 8/10 severity)  Intermittent fever 100.5.  Medications to relieve symptoms:  Acetaminophen 500 mg BID and Ibuprofen 250 mg BID.  2/24/21 - Diagnosis aseptic meningitis and abnormal liver function tests.  Suspended atorvastatin, acetaminophen, ibuprofen.  Start Medrol dose pack, 24 mg/d down to 4 mg/d over 6 days.  3/2/21 resume atorvastatin.  Symptoms improved with Medrol, but partial rebound after stop Medrol.  Gradual improvement, but not back to baseline until 3/17/2021.
Intense pain in left deltoid area after pneumovax for 48 hours, improved by 72 hours
joint aching, hot flashes, diffuse myalgia; liver test really elevated; 2NOV93 devel noc sweats, anorexia & aching all over; 10JAN94 dx acute leukemia-MD feels sx were not related to vax;
Patient had 4 cm area at vaccination site of redness, warmth, firm to touch.  No evidence of discomfort.
Excessive thirst with both courses for four days, and no, I am not a diabetic, and no, I was not dehydrated prior. 2nd course, 2nd day, chills to the bone, slept EIGHTEEN HOURS.
ARM DISCOMFORT AT INJECTION SITE; PAIN WENT UP TO LEFT UPPER CHEST; PAIN WENT UP TO COLLARBONE NEAR ARMPIT / INCREASED PAIN; COUGHING; EXCRUCIATING PAIN IN SHOULDER BLADE; TIRED A LITTLE BIT; This spontaneous report received from a patient concerned a 43 year old male. The patient's weight was 245 pounds, and height was 77 inches. The patient's concurrent conditions included: allergy to nuts, fish allergy, wheat allergy, and environmental allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211D21A and expiry: 11-APR-2022) dose was not reported, administered on 12-JAN-2022 for prophylactic vaccination.  No concomitant medications were reported.  On JAN-2022, the patient experienced tired a little bit. Treatment medications included: ibuprofen. On 14-JAN-2022, the patient experienced arm discomfort at injection site, pain went up to left upper chest, pain went up to collarbone near armpit / increased pain, coughing, and excruciating pain in shoulder blade. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from arm discomfort at injection site, pain went up to left upper chest, excruciating pain in shoulder blade, tired a little bit, pain went up to collarbone near armpit / increased pain, and coughing. This report was non-serious.
itching big nod; hot; swollen; cellulite; This spontaneous case was reported by a consumer and describes the occurrence of PAPULE (itching big nod), FEELING HOT (hot), SWELLING (swollen) and PEAU D'ORANGE (cellulite) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     Concomitant products included OMEPRAZOLE MAGNESIUM, SERTRALINE, MIRTAZAPINE and ETHINYLESTRADIOL, NORGESTREL (CONTRACEPTIVE HD) for an unknown indication.    On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Feb-2021, the patient experienced PAPULE (itching big nod), FEELING HOT (hot), SWELLING (swollen) and PEAU D'ORANGE (cellulite). The patient was treated with AZITHROMYCIN for Adverse event, at an unspecified dose and frequency. On 02-Mar-2021, PAPULE (itching big nod), FEELING HOT (hot), SWELLING (swollen) and PEAU D'ORANGE (cellulite) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
pt devel t102-104 ax; APAP used to keep fever down; elevated temp lasted for 24-48 hrs;
My husband received the Pneumonia vaccine 23 on Friday January 3, 2020 at Pharmacy. Shortly after he said it was painful. Took an extra strength Tylenol. Sat. am was tired slept almost all afternoon. Said his arm hurt. Took 2 extra strength Tylenol total that day. Sunday morning went to church. Came home his arm hurt and I looked at it and it was beet red, hot to touch, swollen and went several inches across and about 12 inches long it went from above the Elbow to down close to his wrist. He looked like he was carrying a loaf of bread on his arm. We called the pharmacy and I explained the problem. He said no I never heard of that before. If it was still bad on Mon. See the family doctor. Well I was concerned. We went to Clinic and he was seen and the PA said it was Cellulitis and gave him a strong dose of antibiotics. About 2 days later it improved. Now it's almost clear. I am telling you this so you can help educate pharmacists who give the vaccine. Thank you.
a patient had an unspecified blood test to determine the VARIVAX titre on an unspecified date in "12/2018" which yielded an unspecified "low titre".; Information has been received from a nurse practitioner referring to a 25 years old female patient. There were no medical history, concomitant medication, or drug reactions/allergies.  On an unknown date, the patient was vaccinated with an unknown number of varicella virus vaccine live (Oka/Merck) (VARIVAX) (injection, lot #, expiration date, dose, strength, route and frequency were not reported) for prophylaxis.   On an unknown date in December 2018, the patient had an unspecified blood test to determine the varicella virus vaccine live (Oka/Merck) (VARIVAX) titre which yielded an unspecified low titre. There was no treatment given for the event. The patient had sought medical attention. The outcome of the event was not reported as not recovered. Causality assessment was not provided.
Very sore deltoid muscle for the past 10 days. Patient states soreness is only in the muscle, but it is restricting range of motion.
Guillain Barre syndrome after receiving Tdap, influenza vaccine and Pneumovax.
Large R axillary adenopathy . Present approximately 24 hours. Currently stable. Outcome to be determined.
Pfizer on 5/14 and 6/9. Positive on 12/3
Fever , chills,  Body Ache all over body,  Joint Pain (worse in hips ) Injection site swollen  The PT cannot life her arm
the patient has been administered dose of vaccine which was improperly stored.; This spontaneous report has been received from a vaccine coordinator who was also a medical assistant concerning a patient of unknown age and gender. The patient's medical history, drug allergies, concurrent conditions and concomitant therapies were not reported.  On 23-MAY-2019, the patient was vaccinated with an improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) with lot number R002510 and expiration date on 25-JAN-2020 (dose, dose number, route of administration and anatomical location were not provided), for prophylaxis.   It was reported that on 19-MAY-2019, 20-MAY-2019 and in 2020 (conflicting information), the vaccine was exposed to a temperature above 9 degrees Celsius: 16.4 degrees Celsius for 5 hours and 30 minutes, and below 2 degrees Celsius: 0 degrees Celsius for 9.8 hours. There was no previous temperature excursion. The call was placed because of a Digital Data logger report.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1906USA004562:
6/9 Fever. 6/10 Ear infection/ rash over body- 4th day after vaccination. Prescription Tylenol- Motrin 2 pack- started Friday.
My swollen lymph nodes in my left armpit don't worry me, but when I saw ecchymosis/a bruise on the side of my left breast on April 18 at 10pm I got worried. On April 19, at 8am, the bruise on my breast was significantly larger and darker. I didn't get hit or bump into anything in recent memory and the bruise doesn't hurt when I touch it. The bruise is dark purple and covers a third of my breast under my swollen armpit. I sent my PCP a photo and he said to go to urgent care for bloodwork and diagnosis. Thusly, I went to Urgent Care and the doctor there thought it has to do with me taking Advil for the swollen lymph node pain (one pill per day on April 17th and 18th) and drinking one glass of champagne on April 16th.
Mother states patient left arm became red and swollen after 2 hours of injection.  Patient seen and advised ice packs, Benadryl elevation and return in 24 hours if no improvement.
I had been taking Moderna prior.  Was fully "vaccinated" in November 2021.  Started having adverse events on January 1st,  2022, which was precipitated by a sinus infection.   I believe I had an immune reaction from the vaccine in my system that was prompted by the sinus infection.   I felt that my whole respiratory system was inflamed, dizziness, loss of taste and smell.  After the symptoms didn't go away, I went to get the booster, and upon arriving home I slowly began to have an inability to get oxygen to my brain.  I was able to get air into my lungs, but it was no longer entering my brain.  It seems it was dysautonomia.  Also swollen veins and red feet, burning skin.  Blood sugar crashes, or something similar, gluten intolerance, sugar intolerance, pretty extreme sensitivity to salt, things like that. I can't even eat gluten free bread.     I still cannot exercise without my whole body being sore and my muscles burning intensely, not just regular soreness.     After nine months of blackouts every day, I used a nebulizer with a few drops of food grade hydrogen peroxide, and the rest purified water, despite doctors telling me not to, and that helped.  I have been diagnosed with POTS.  I have been to the emergency room with frequent chest pains.  My blood pressure was pretty erratic for the first year, but now it seems to be nausea and extreme fatigue.
AFTER THE PATIENT GOT THE VACCINE 5 MINUTES LATER, HE STATED FEELING DIZZY, I PROVIDED HIM THE AMMONIA INHALANTS AND FAINTED. I WAS HOLDING HIS HAND AND I LAY HIM ON THE FLOOR. PATIENT DID NOT HIT HIS HEAD. HE PASSED OUT FOR ONE MINUTE. 911 ARRIVED AND CHECKED HIS VITALS AND WAS FINE.
7-18-11 VCV administered to (L) upper arm SubQ; pt c/o sl. itching. Minimal redness noted. 15 minutes after cool pack applied pt mom stated itching subsided so pt released to home. 7-20-11 Mom brought pt back as swollen red area approximately equal to 2" x 1 1/2" sl. raised at site. No fever or malaise noted in pt. Mom had been giving MOTRIN & BENADRYL. Mom advised BENADRYL & MOTRIN prn.
Pt received shots approx 10:30AM mom called 4hr later and said infant cried and screamed x 2hrs wouldn't feed, low grade temp 99.9. 6/1/06 Received medical records from hospital which reveal patient experienced irritation, crying w/anorexia 4-6 hours s/p vaccination & was admitted overnight for observation w/dx: suspected irritability reaction to DTaP.  Had also changed formula recently.  Pregnancy & delivery were unremarkable.  Exam following AM was WNL & was d/c home/ss
Patient came by today stating that she had a localized rash to the Shingles shot the next day after  her shot.  She said she it was a little itchy and felt like a stink at the area near the opposite side of her left elbow.  She said a few weeks later it appeared to migrate down to her wrist and that is when she decided to make an appointment to go see her dermatologist on 12/16/2022.  Patient will keep us posted after her appointment.
reporter stated that relative devel rash on back,arms & shoulders which she thought was chicken pox following varicella vax;f/u indicated that pt recvd 1 dose of vax on 25aug95 & subsequently devel urticaria pigmentosa on 31aug95;
Moderate Dermatographia, welts/rash appear after only mildly grazing my skin. My ears and face constantly feel flushed. Doctor put me on Medrol pack for 5 days, it helped with rash for the duration, but provided no cure as of the time of writing.