chrisvoncsefalvay/vaers-outcomes huggingface dataset:
sore arm; maybe was feeling a little beat up next day; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 65-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 6 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 IMMUNIZATION, reaction(s): "feeling a little beat up next day", "Sore Arm"; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 IMMUNIZATION, reaction(s): "feeling a little beat up next day", "Sore Arm"; Bnt162b2, bnt162b2 omi ba.4-5 (DOSE 3 (BOOSTER), SINGLE), for COVID-19 IMMUNIZATION, reaction(s): "feeling a little beat up next day", "Sore Arm"; Bnt162b2, bnt162b2 omi ba.4-5 (DOSE 4 (BOOSTER), SINGLE), for COVID-19 IMMUNIZATION, reaction(s): "feeling a little beat up next day", "Sore Arm"; Bnt162b2, bnt162b2 omi ba.4-5 (DOSE 5 (BOOSTER), SINGLE), for COVID-19 IMMUNIZATION, reaction(s): "feeling a little beat up next day", "Sore Arm". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm"; MALAISE (non-serious), outcome "unknown", described as "maybe was feeling a little beat up next day". Additional information: the patient was vegan.  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-202300289475 Same patient/vaccine, different dose, similar event;US-PFIZER INC-202300289476 Same patient/vaccine, different dose, similar event;US-PFIZER INC-202300289477 Same patient/vaccine, different dose, similar event;US-PFIZER INC-202300289478 Same patient/vaccine, different dose, similar event;US-PFIZER INC-202300289479 Same patient/vaccine, different dose, similar event;
vesicular rash onset on 22DEC98;sl fever of 100 for 1 day;no antipyretics given;no other complications noted;chickenpox dx less than 50 pox on body;
Pt stated pt started having body aches, headaches, fever( ranging from 99 to 102) and cough.  Pt stated on Tuesday pt started having diarrhea.
Reports feeling hot and faint immediately after vaccination, transported to ER where she said after lying down she started to feel better.  Does report a history of "fainting spells"  No admit - patient was released from ER.  Upon follow up she denies any further adverse reactions.
About three weeks after my second dose I developed Microscopic Colitis. I'm still having diarrhea which have been going on for 2 months. Just started prescription budesonide on 06/25/2021.
Shortly after first dose, patient complained of itching and localized "tightness" in arm at the site of injection.
pt fell asleep p/shots; woke up fussing; no crying; was pale-white, limp, glazed eyes, & not focusing; mom wiped down w/water to ince circulation; 15 mins cried & became pink; called ER no visit or contact w/MD;
This spontaneous report as received from a Nurse Practitioner refers to a college aged patient. The patient was vaccinated with the second dose of 0.5 ml M-M-R II (Lot# and expire date unspecified) intramuscularly on 12-JUL-2012. No other co-suspects were reported. No concomitant medications were reported. It was unspecified if the patient had sought medical attention. No adverse effect reported. Additional information has been requested.
liver and pancreas enzymes were high; liver and pancreas enzymes were high; high blood pressure; belly pain; headache; A spontaneous report was received from a 54-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced high blood pressure 100/100 mmHg, headache, belly pain and her liver and pancreas enzymes were high.  The patient's medical history was not provided.  Concomitant medications of the patient included lisinopril and atenolol for blood pressure. The patient had performed lab test before receiving the vaccine and the results were normal.  On 26-Feb-2021, the patient received her first dose of mRNA-1273 (lot/batch: 001A21A) intramuscularly for prophylaxis of COVID-19 infection.  On 28-Feb-2021, the patient went to ER due to high blood pressure 100/100 mmHg, headache and belly pain. Her lisinopril dose was increased to 20mg/day. On 1-Mar-2021, patient went again to ER and there lab test and an scan were performed and she was told that her liver and pancreas enzymes were high. On 4-Mar-2021 belly pain, high blood pressure and "liver and pancreas enzymes were still there". Lisinopril increased dose did not work and so they changed to atenolol 25mg/day.  On 18-Mar-2021,the patient has an appointment with her cardiologist.  Seriousness criteria for the events of liver and pancreas enzymes were high was life threatening.  Action taken with mRNA-1273 in response to the event was unknown.   The outcome of all the events was unknown.  No further information was provided.; Reporter'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.
Patient had dystonic reaction few hours after 2nd dose of Pfizer COVID19 vaccine invlovling repetitive movements of arms/torso/neck/shoulders and twisting of body as well as numbness in arms/legs. Went to ER and CBC/CMP reassuring. Given IV Benadryl with resolution of symptoms.
dx w/gastroenteritis, also seen 5/4/99 dx w/intuss - & treated in hosp, w/air enema
General severe arthralgia, severe muscle pain all over, slight mental fogginess, headache, chills, blotchy red circular rash on right arm 2 days after vaccine, swelling and pain at injection site.
October of 2021 I had a seizure... Spent the night in the ER, they did MRI CT EEG... Mentioned EEG may have had some abnormalities, but had nothing to compare it to. I had another seizure Feb 2022 10 minutes long... EEG in April 2022 showed no abnormalities... Still having seizures but now they are only 10-30 second absence seizures
A Consumer report has been received. The report concerns a 1 month old, male consumer, who had been receiving intramuscular SYNAGIS, 15.0 Milligrams per kilogram, Unknown and Nasal FLUMIST QUAD. Concomitant medications included Furosemide, Levothyroxine sodium and Acetylsalicylic Acid. SYNAGIS started on 22-Nov-2013 and FLUMIST QUADRIVALENT started on an unknown date. The patient experienced red spot on right leg (Preferred term: injections site erythema) which started on 22-Nov-2013. The patient recovered from the event of red spot on right leg on an unspecified date. The report was considered to be non-serious. Summary of follow-up information received by AstraZeneca/Medimmune on 03-Jan-2013 from consumer: new suspect drug FLUMIST was added. Corrected report 15-Jan-2014: Event onset date added. Reported details updated Concomitant drugs added.
Immediately after vaccine arm was Painful sore arm 1st 3 days.  Soreness went away. After that my arm started feeling slightly itchy for a few days right when I had my shot.  1/21/21  arm swollen and itchy with a red rash.  I took Benadryl and put cortisone on area.
Information has been received from a 14 year old female consumer who "about 3 months prior" was vaccinated with GARDASIL. On an unspecified date the consumer experienced headaches. The patient sought unspecified medical attention. At the time of the report the patient had not recovered. Additional information has been requested.
10 minutes after receiving the first Pfizer vaccine to the left arm, the patient developed a sensation of tongue tingling and "mouth fullness". This persisted for over an hour. She described it as mild, and she felt also as if she was thirsty. Denies any trouble breathing, chest pain, nausea, lightheadedness, or other reported symptoms. Exam of the mouth including the tongue, lungs, heart, and visible skin were within normal limits. Vitals included BP 124/84, P 84, R 16  She was taken to the medical pod, where she was given 25 mg oral of benadryl with notable improvement. Tongue tingling improved, but is still present. She was advised to go to the ER for further eval for concerns of developing severe allergic reaction or anaphylaxis, but she refused. She signed an AMA form. She has no one to drive her, but states she feels safe to drive. She was advised benadryl if symptoms continue to persist. She should not get next injection until speaking with allergist, and it being done in a controlled environment. Urged ER if any worsening symptoms.
This spontaneous report as received from a healthcare professional refers to a 17 month old male patient. There was no pertinent medical history and no drug reactions or allergies. On 25-FEB-2014, the patient was vaccinated with VARIVAX (Merck) lot# H015136, exp 09-AUG-2014, 0.5 ml, subcutaneous for M-M-R II, lot # J002502, exp 28-FEB-2015 (dose and route not reported). On 28-MAY-2014, the patient was inadvertently vaccinated with VARIVAX (Merck) lot # H022156, exp 18-DEC-2014 (dose and route not reported) and M-M-R II lot # J002502, exp 28-FEB-2015 (dose and route not reported). Concomitant therapies included SINGULAIR. On 28-MAY-2014, the patient experienced rash on his face and torso. The patient's mother seek for medical attention (called the office). No lab diagnostics performed. No treatment given for the events. The outcome of rash on his face and torso was reported as not recovered. This is one of two reports from the same patient (1406USA006616). Additional information has been requested.
Headache body pain fever ..24 hours Large area inflamed on arm hot and painful .. ongoing
developed shot breathing went to ER; This is a spontaneous report from a contactable consumer (parent). This consumer reported for a 21-year-old male patient (son) that received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The consumer reported that the son had his first shot of the vaccine and he developed shot breathing went to ER. Outcome of the event was unknown.  Information about lot/batch number has been requested.
p/vax pt devel high fever 104F; head & neck hurt; eyes rolled back in head; lost eyesight; almost went into convulsions; lethargic; dx w/encephalitis-viral infect
3 inch red, inflamed circle around injection site as of today, patient feels area is "getting better".
Patient was admitted s/p hysterectomy, found to have PE and AKI. Patient treated with heparin drip, transitioned to Eliquis and discharged
At approximately 3:29PM on 5/10/21, began to have adverse effects after receiving her Moderna dose #1. She temporarily lost vision in both eyes as well as her hearing. She became cold to the touch, red, and clammy. Patient reported feeling like she was feeling like she was blacking out. We had given her water, wiped her off with towels, and fanned her. 911 was called at this point and her blood pressure was checked which showed 122/91mmHg. Management came over to the pharmacy and was helping fan her as well. The fire dept and EMTs showed up soon after and took over. Patient?s hearing and vision were restored and started feeling back to normal. Patient then declined further medical intervention from EMT?s and went home.
PATIENT DEVELOPED A BRIGHT RED RASH WITH A WELT ABOUT 2" PER THE PATIENT THURSDAY NIGHT. I EXAMINED THE SPOT ON FRIDAY AFTERNOON AND IT SEEMED TO BE LARGER THAN 2" (MORE LIKE 6"). SHE WENT TO URGENT CARE FRIDAY AND WAS GIVEN AN ANTIBIOTIC. I FOLLOWED UP WITH PATIENT ON MONDAY AND SHE SAID THAT THE RASH DECREASED BUT STILL ABOUT A QUARTER SIZE ROUND PATCH.
Numbness hands arms face and mouth and lightheaded 30 minutes post vaccine. 12 hours after vaccine 102 fever, severe body aches, chills, stomach ache, and diarrhea.  Took acetaminophen 1000 mg at 2 am.  Stomach issues subsided 7 am, 20 hours after vaccine.  Fever over 101, chills, body ache, and headache remained for 3 days. All symptoms have subsided except right side of face still tingling and numb.
Significant arm pain starting around 5-6pm. Starting at 7pm, had chills, significant rigors, significant body aches. Normal tylenol dosing helped, but symptoms persisted through to 8-9am 1/29. Mild back & joint pain 1/29.
Pain in arm, from shoulder to fingertips. I can barely use my arm from the pain.  It has been almost 3 weeks and the pain still has not subsided.
I have had tinnitus since 2013. Two days after my covid shot (1st) my tinnitus is louder and higher pitched then it normally is.
Patient developed 104.4 temp approximately 48 hours after being given the vaccine. I treated him with antibiotics, IV fluids, cooling methods. CXR does show a new right perihilar infiltrate. However, his fever came down within the next 24-48 hours. Unfortunately, he suffered a cardiac arrest on 1/21/21 in the early morning and expired.
3 days after first Pfizer dose, I experienced heart palpitations and mild chest pain. Heart palpitations happened while at rest. Heart rate would go from roughly 70-80 BPM to 30-40 for a few beats and then return to normal. It happened primarily when lying down. The palpitations occurred most prevalently on days 3-4 after the 1st Pfizer dose. It was sometimes accompanied by mild chest pain. It woke me up a few times per night for about a week with a similar sensation of skipped heart beats and pain. It has mostly resolved, and I am continuing to watch for persistent/recurrent symptoms.
This spontaneous report as received from a Medical Assistant refers to a patient of an unknown age and gender. The patient's concurrent conditions, medical history, historical drugs and concomitant therapies were not reported. On 11-DEC-2017 approximately six months earlier than recommended in the prescribing information, the patient was vaccinated with the first dose of M-M-R II lot # M037096, expiration date 23-AUG-2018 (dose and route was not reported) for prophylaxis. No adverse events reported.
Adverse Event: Severe Auditory Hallucinations and psychosis I am a physician and patient's son. She is a 73 yo woman who has no known psychiatric history who suddenly developed auditory hallucinations and psychosis about 1 month after the administration of the second dose. The onset was sudden and was associated with auditory hallucinations and delusions. She went to the ER and initial work up was negative. Following this she saw a neurologist with expertise in cognition. She was also admitted to the hospital where she had extensive neurological workup which was negative. The symptoms persisted after the discharge. As of this date, the symptoms are waxing and waning and are severe at times. Etiology of this acute de is unknown though one of the differential is vaccine related side effect. Hence I am completing this form.
5/24/21 53 years old female with past medical history of cardiopathy (murmur) presents with numbness to the right arm and leg post vaccination. Patient 12 lead EKG shows some PVC?s. Patient is hypertensive. Vital sign 175/89, 82 HR, 95%, 18 respiration rate, blood sugar is 88.  Patient right fingers are very cold and are turning blue. Patient received second dose of Pfizer. Patient denies any reactions to previous vaccinations. Patient denies any chest pain and palpitations. NP and Paramedic by the stretcher monitoring patient. Vitals sign rechecked 163/103, 86, 95%, 19. Patient is still hypertensive. Patient denies any history of HTN. Rescue transported patient to  hospital.
< 1 minute after Seasonal Flu vaccine administered IM to right arm; right arm developed hives and additionally did the upper torso.  Patient received 25mg Benadryl and hives subsequently resolved, No respiratory symptoms. Observed for at least 30 minutes post vaccine and did well.
Large induration approx 18 mm;warm to touch & decrease in size per mother.Tx w/ warm compresses & Tylenol.
8NOV welts on face, 9 & 10NOV fever 101, 8NOV & as of 5DEC continued lethargy, h/a, body aches; MD called 1 wk p/shot, MD visit 2 wks p/shot; MD dx p/test results was malaise & fatigue;
Headache pretty soon after shot that continues.. 15 hours after, fever, chills, vomiting, nausea, body aches
I missed my period a few weeks after I took the vaccine.  I would have ordinarily gotten it the last week of August, and that skipped entirely, so I went from July to September with no period at all.
Circular erythematous area on right thigh approximately 3 weeks after first set of immunizations (child previously unimmunized). Mupirocin ointment prescribed.
STARTED WITH BODY ACHES ON DATE OF VACCINATION WITH POSSIBLE TEMP. ON FRIDAY (2 DAYS POST) PT. WOKE UP WITH JAW PAIN AND SHORTNESS OF BREATH.
Started feeling weak, achy, and tired around 9:30 PM. Realized I was shaking and freezing despite wearing thick layers and laying in bed. Felt dizzy on standing, and woke up the next morning with a mild headache and persistent weakness, fatigue, and body aches.
Onset of unusual hand movements / possible tics, as well as irritability and aggressive behavior. Seen by Dr. (pediatric neurology) and not thought to be c/w Sydenham's chorea.
This is a spontaneous report from a contactable consumer or other non healthcare professional. A 53 year old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included food allergy from an unknown date and unknown if ongoing known allergies to Shrimp and opioids, toxicity to various agents from an unknown date and unknown if ongoing. There were no concomitant medications. The patient experienced psoriatic arthritis and after the first shot had pain and swelling on an unspecified date with outcome of recovering. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 01Apr2021 with Nasal Swab. Therapeutic measures were taken as a result of these events with Acupuncture, chiropractic, pain meds, Humira.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Cold; loss of appetite; Chills; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (Cold), DECREASED APPETITE (loss of appetite) and CHILLS (Chills) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced NASOPHARYNGITIS (Cold), DECREASED APPETITE (loss of appetite) and CHILLS (Chills). At the time of the report, NASOPHARYNGITIS (Cold), DECREASED APPETITE (loss of appetite) and CHILLS (Chills) had not resolved.            Concomitant medications were not provided.  Treatment information was not provided.
Janssen COVID-19 Vaccine EUA"  Sunday 4-11-2021 woke up with mild itch and Hives on shoulders and face. At 12PM I went to Urgent Care, and was given prescriptions Cetirizine HCL 10 MG Tablets. when i got home, I notice my lips was beginning to swell and forehead with Welt.  Monday 4-12-2021 The Hives spread to my arms legs, feet, back and neck....I went to the ER. at 10:37AM I was given by IV the following: dexAMETHasone (Decadron) / diphenhydraAMINE (Benadryl) / famotidine (PEPCID) and Sodium Cloride (NS) I stay for about 4-5 hours. where the Hives on the forehead, shoulders and arm was starting to disappear...I was discharged. with Prescriptions: Famotidine and to continue to take the Cetirizine but 2 times a day rather then once a day that was previously prescribed, and to take Benadryl twice a day within 6 hours. Hives was appearing to decrease by the evening, on shoulders, forehead Tuesday 4-13-2021 I woke up with hives all over my stomach, sides, back and inner thighs. some spots on forehead and welts on neck and face.
Migrane, full body aches, nausea, chills, fatigue. All went away within 24 hours
Eleven days after shot I developed cellulitis in my left breast. I have breast implants. This cellulitis covered my entire breast. It was very hot to the touch and hurt. Since it began on a Saturday I waited until Monday to go to my doctor. He diagnosed it as cellulitis and gave me a script for Clindamycin and a steroid dose pack. I started taking those yesterday. Today the redness has gone down quite a bit and the pain is diminished. It is still red though. He informed me to take second shot in the other (right) arm. I also take Actemera for my RA which also lowers my immune response. I was worried about taking it because of my lower immunity. I even called MODERNA, but they and my rheumatologist told me it would be all right. My second shot is on March 2nd. I will not be getting my IV dose of Actemera until three weeks after the second Moderna shot.
@ 1413 patient reported feeling hot flashes and chills @1416 Vitals were stable with BP 128/62, Pain 0/10, O2 sat 98%, pt denied history of anaphylaxis, no current dizziness, no facial swelling.  @1430 Pt. denies any s/s of reaction, reported that she feels much better. Pt stayed an additional 20 minutes to be monitored by medical staff.  @1441 pt was discharged and ordered to go to ED if any sudden changes occur
About five months after receiving the second dose, I came down with Shingles. It is located on my right side from my naval around to my back. It's about two inches high and two inches below my waist. I have had these shingles for around five weeks now. It's more scarring at this point. I went to the urgent care and was given an anti-viral medication, Valacyclovir, 1 gram tablets, to take three times per day for seven days.
On 12/9/2010, Redness area 5.5 x 4.5 inches in lest upper arm, with warm and firm to touch and pain. On 12/10/2010, redness area came down to anterial part of left upper arm, and pain moved up to left side of shoulder and neck.
Sore arm, redness around injection site, red swollen under arm area, fever, chills, headache, fatigue
swelling/redness at sight was in lab they sent her over to the ER. Dr who she had seen for a well child that day was notified and went and checked on patient as well as the RN. Patient and mother were brought back up to clinic and monitored for about 30 mins longer.  RN drew labs. Provider said patient was just fine and well. Patient left with mother.
3/18/2021 9:00am Vaccine administered Around 2:00 pm Chills and stomach pain Around 3:00 pm 101.2 Fever, chills, worsening stomach pain, vomiting, light headed Around 5:00 pm went to ER on advisement of Doctors office While in ER experienced more vomiting, fever chill, stomach pain ER administered IV fluids, Tylenol, blood draw 10:00 pm Released from ER and went home 3/19/2021 No appetite, extreme fatigue, some dizziness, slight headache, chills in evening 3/20/2021 Very little appetite fatigued, some dizziness, backache Around 5 pm stomach pain which subsided an hour later, 6:00pm chills
PATIENT STATED SHE RECEIVED HER 2ND DOES THEN LATER DEVELOPED "SEVERE" SIDE EFFECTS OF COUGH, HEADACHE, SORE THROAT, LEFT SIDE NECK PAIN AND FEVER OF 102.2, CHILLS, BODY ACHES, AND SORENESS.
Hep B given on 4/2/08.  Client reports feeling tired & soreness at injection site by the evening.  On 4/4/08 she noticed an itchy red bumps starting on her legs and progressing to her arms, hands, face and entire body.  She took Advil on Friday for soreness & feeling tired.  She took Benadryl only one dose on Sunday (4/6/08).  Rash gradually subsided by Tuesday 4/08/08.  She denies respiratory problems.  Dr. notified for guidance 5-1-08.  See email Hep B vaccine not to be completed.