chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Large blood clot in right leg(DVT). Currently on blood thinners; This is a spontaneous report from a contactable consumer (patient). A 58-year-old male patient received first dose of bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Right on 11Aug2021 13:00 (Lot Number: FC3180) as single dose (at age of 58-year-old) for covid-19 immunisation. Medical history was reported as none. He had no known allergies. Concomitant medications were not reported. Facility type vaccine: pharmacy or drug store. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 19Aug2021 06:00 patient experienced large blood clot in right leg, deep vein thrombosis (DVT). Currently on blood thinners. Event resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Patient was admitted for the event on unknown date. Patient was treated with Coumadin and Lovenox. Patient did not have COVID prior vaccination. No COVID tested post vaccination. Patient had not recovered, at the time of the report.
Anaphylaxis - shortness of breath, wheezing, diffuse urticaria and skin erythema, lip and throat swelling
rash with itching; tired; headache; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (rash with itching), FATIGUE (tired), HEADACHE (headache) and VACCINATION SITE PAIN (sore arm) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A21A and 011M20A) for COVID-19 vaccination.     Concurrent medical conditions included Autoimmune disorder. Concomitant products included BISMUTH SUBSALICYLATE (PEPTOBISMOL) for an unknown indication.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Feb-2021, the patient experienced RASH PRURITIC (rash with itching), FATIGUE (tired), HEADACHE (headache) and VACCINATION SITE PAIN (sore arm). On 05-Feb-2021, RASH PRURITIC (rash with itching), FATIGUE (tired) and HEADACHE (headache) had resolved. At the time of the report, VACCINATION SITE PAIN (sore arm) had resolved.            No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 20-Jul-2021: Additional information include email address provided.
2 pts did not seroconvert on 3 doses of hep B vax.
SEVERE HEAD PAIN, GENERAL TIREDNESS, MUSCULAR PAIN IN THE NECK, BACK AND ONE EPISODE OF CHILLS
Pt received Td booster in left deltoid 8/16/04 around 4PM and called the Health dept. on 8/17/04 reporting the usual soreness around injection site in left deltoid, but also reporting soreness in left arm and bad pain in anterior area of upper left thigh. States pain was bad enough to cause her to limp and that she could hardly walk. Several hours later, the pain moved to lateral aspect of upper left thigh and was dull and throbbing. She was seen by a physician on 8/18/04 who told her leg pain was not assoc. with vaccine in arm. Pain lessened after moving about but returned after resting. Pain in leg lasted until 8/19/04 and then resolved itself. On 8/23/04 she stated no more problems with leg or arm.
No adverse event; there might have been a wrong dose given to a customer; customer received 1 dose of the Primary series, then received a Moderna Covid-19 Vaccine, Bivalent dose; This spontaneous case was reported by a pharmacist and describes the occurrence of INCORRECT DOSE ADMINISTERED (there might have been a wrong dose given to a customer), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (customer received 1 dose of the Primary series, then received a Moderna Covid-19 Vaccine, Bivalent dose) and NO ADVERSE EVENT (No adverse event) in a 19-year-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 13-Oct-2022, the patient received second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 13-Oct-2022, the patient experienced INCORRECT DOSE ADMINISTERED (there might have been a wrong dose given to a customer) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (customer received 1 dose of the Primary series, then received a Moderna Covid-19 Vaccine, Bivalent dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INCORRECT DOSE ADMINISTERED (there might have been a wrong dose given to a customer), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (customer received 1 dose of the Primary series, then received a Moderna Covid-19 Vaccine, Bivalent dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for INCORRECT DOSE ADMINISTERED (there might have been a wrong dose given to a customer) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (customer received 1 dose of the Primary series, then received a Moderna Covid-19 Vaccine, Bivalent dose).    No concomitant medication were reported.   Patient received 1st dose of the Moderna Covid-19 vaccine on 5-OCT-2021.  No treatment information was provided by the reporter.
Narrative:  This patient received one dose of Janssen COVID 19 vaccine in June 2021. The patient present presented to the ED on 8 June with a cough, wheezing, shortness of breath and sore throat. The patient was admitted to the hospital with COVID 19 with mild hypoxia and community acquired pneumonia. The patient was discharged on 14 June on oxygen, but in stable condition. Reported per EUA.
Flu-like symptoms recurring about every 2 weeks chills, weakness, sore throat, nasal drip while sleep mainly. I did not notice the loss of smell totally until end of Nov. Ignored it but went to pharmacy in Dec. I have been concerned of my continued flu-like illness after the flu shot in Nov. 7, 2013. But I am not concerned about anything other than getting better and to the bottom of my illness. Ironically, when I contacted you the thing you told me to do was to go to the doctor. Well, I went yesterday 1-7-2014. And they could not find anything that was too unreal. The doctor told me my blood pressure was up. I had not taken the B/P meds prescribed because I couldn't function. The main thing that made me feel better was the pain in my (Rt) side of face sinus areas and ear were found. But my left ear was unable to be seen clearly due to white matter. My (Rt) ear was tender due to me always touching it by it being itchy and painful. Then I remembered - I just underwent a complete house clean-up due to mildew on the walls. And at about the same time I got the flu shot. I was in contact with going into a closet and finding mold. This is one of my biggest allergies. I had a Dr check for mold problems in Feb 2012. When I found the walls mildewed. Areas were repainted and treated. I have been hard of hearing for a while. People would ask me why am I hollering. So, it's possible I already had sinus or nasal problems. Because I was on FLONASE nasal spray before. So, the Dr Rx was FLONASE both nostrils. She stated if I had problems with the nose I possibly couldn't smell. That sounds normal for me. So, I'm O.K. I'm just better to know there's a reason. The flu-like symptoms, are getting weaker and weaker, On the 7th of this month it was not too bad. I've also tried to increase vitamins and stay in more and away from other sick people. Thank you for sending me the papers to get information. I'm sure this will clear up in time. Colds have always been the main illness that stops me.
Neurologist has seen many other patients who have received the Moderna Covid-19 vaccine and who now have Migraine Headaches. This spontaneous case was reported by a patient and describes the occurrence of MIGRAINE (Neurologist has seen many other patients who have received the Moderna Covid-19 vaccine and who now have Migraine Headaches.) in a patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced MIGRAINE (Neurologist has seen many other patients who have received the Moderna Covid-19 vaccine and who now have Migraine Headaches.). At the time of the report, MIGRAINE (Neurologist has seen many other patients who have received the Moderna Covid-19 vaccine and who now have Migraine Headaches.) outcome was unknown.        The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported.   This case was linked to MODERNATX, INC.-MOD-2021-187590 (E2B Linked Report), Sender's Comments:  MODERNATX, INC.-MOD-2021-187590: Same reporter (MOD22-026949)
This report describes a 58 y.o. female who did not respond to the Hep B vaccine recombinant (Engerix-B) immunization series. The subject is a moderate cigarette smoker. No other medical history, concurrent conditions, or concurrent medications were reported. She received no concurrent vaccines. The subject experienced no adverse events following previous immunizations. The subject's birth weight was 6.68 pounds. The subject received Engerix-B on 8/1/01, 9/11/01, and 2/5/02. Lots of vaccine administered were ENG5235A4 (1st 2 injections) and ENG5262A4 (3rd injection). A titer (NOS) measured 2 months after the 3rd injection on 4/5/02 showed a value of "4" (10 being considered a protective level). The reporting nurse considered the inability to respond to the Engerix-B immunization series as possibly related to Engerix-B administration.
extreme nausea; headache; lip swollen; tongue swollen; This spontaneous case was reported by a consumer and describes the occurrence of LIP SWELLING (lip swollen), SWOLLEN TONGUE (tongue swollen), NAUSEA (extreme nausea) and HEADACHE (headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jan-2021 at 9:00 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jan-2021, the patient experienced LIP SWELLING (lip swollen) and SWOLLEN TONGUE (tongue swollen). On 21-Jan-2021 at 12:00 PM, the patient experienced NAUSEA (extreme nausea) and HEADACHE (headache). At the time of the report, LIP SWELLING (lip swollen), SWOLLEN TONGUE (tongue swollen), NAUSEA (extreme nausea) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.    No treatment information was provided.
Queasy (nauseous), muscle weakness, loss of appetite, (lost 5 lbs.) tired, eyesight, no energy. (No temperature).
Nine days after receiving first dose, I got a bright red rash on my left arm. It was a bit itchy at times. It faded after about 3 days. I noticed today (3/21) that the bright red rash came back, again with a bit of itching.
Patient was fully vaccinated with Moderna on dates 1/14/2021 and 2/8/2021 and had a COVID-19 positive test on 7/9/2021.
pt recv vax; area of inject hot to touch, swollen; tx w/ ice to leg for 15 min; apap given;
on 1/11, left arm noticed knot approximately 1 inch by 2 inches.  it is red, warm to the touch, and itchy/sore,    took Advil and used cold compress for approx 20 minutes. on 1/12 left arm knot grew, still warm to the touch, red, and itchy.  now approx 2x3 inches
Enlarged and tender Supraclavicle lymph nodes on left side. I expect enlargement of lymph nodes but not the supraclavicle.
0925 The pt was here for vaccination. 0930 Pt alert, active & responsive, then nurse started giving Rotavirus (R.V.) orally. Nurse gave R.V. about 2 drops at a time. 0935 After giving 3/4 dose of R.V., the pt started coughing & spitted out small amount of clear liquid. Pt's mother held upright & patted the pt's back. Pt spitted out small amount of clear liquid. Pt looked lethargic, no response to stimulatiion, weak pulse & slow respiration, lips pinkish & skin warm to touch. 0940am informed clinician. Clinician came & assessed the pt's condition. Nurse continued to stimulate pt. 0942 Pt opened both eyes, awake, active & response to mother. Clinician continued to assess pt. Clinician advised no need to give the remaining of R.V. vaccine & just to give the other vaccines today & carred. 0955 PCV13, Pediarix & HIB IM given & pt tolerated well. Instructed pt's mother to stay in the clinic for 15 minutes to monitor for adverse reaction. 1010 nurse assessed pt without any adverse reaction noted. Pt was bottle feeding. 1018 pt's mother & pt left the clinic without notifed nurse.
Fully vaccinated with Moderna x3. Tested positive for Covid-19 02/11/2022. Admitted to local Medical Center on 02/11/2022. Expired on 02/12/2022 while still hospitalized.
shaking chills Narrative: Per supervisor report: "received her COVID vaccine on 10/12/21 and has been up since 12 am [midnight] today 10/13/21 with c/o "shaking trying to keep warm under two blankets".
Patient had 104 degree fever F, swelling on injection site, rash, sensitive to touch.
I started having heart palpations about 14 hours after the shot. They lasted about an hour the first time. Then I got them about four more times before my second shot (which I got today).
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Jan2021 as dose 1, single (Lot number: EK9231), on 01Feb2021 as dose 2, single (Lot number: EL3249), on 25Sep2021 as dose 3 (booster), single (Lot number: FC3184) and on 02Apr2022 as dose 4 (booster), single (Lot number: FJ9943) for covid-19 immunisation. The patient's relevant medical history included: "hypertension" (unspecified if ongoing); "hypothyroidism" (unspecified if ongoing); "hypercholesterolemia" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL; LEVOTHYROXINE; ROSUVASTATIN, start date: Mar2022, stop date: 04Aug2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Patient had no known allergies. Paxlovid was received as a therapeutic measures for the adverse events. Covid rebound symptoms began 15Aug2022 which was five days after completion of paxlovid. mild symptom course. Rebound symptoms still resolving 9 days later. also had significant metallic taste in mouth throughout treatment course. worsened 1-2 hours after each dose. Resolved with end of paxlovid course. present 05Aug-10Aug2022. No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on available information in the case the reported events Vaccination failure and Covid 19 are assessed as related to suspect drug .
The day after my vaccine I started bleeding between periods which is very unusual for me. It messed up my menstrual cycle for about a month
He began experiencing seizures 4 days after the shot. He has Grand Mal Seizures and has been diagnosed with epilepsy. He takes 2 bc of Trileptal 2 x per day.  Had episode of blue around the mouth face pastey "seemed unresponsive, eyes rolled "back in head. Lethargic. Doing ok now breathing ok . Was not eating at time- had just woke up. Had laid on bed- was crying. Acting ok now- was pastey gray for a while. Mom tried mouth to mouth- didn't see chest rise. Passed out? How long 2-3 mins. Breath holding spell. (URI) Mom uncomfortable with dx- doesn't believe it was.   EEG for seizure activities. Has no development so will not do further w/u unless has other episodes or symptoms.  Bright red diaper rash- tried ointment no help. Getting worse. now 4-5 open, draining now in diaper area. Cold for 2 weeks. no fever. Kept waking up fussy. Seen 04/24 and Dx with URI- seems to be getting worse. Breathing shallow, crying out in pain during sleep. no fever. Generally very happy, nose stopped up, lungs/chest clear.  Nose congested 2hrs to URI and allergies. OK Claritan, Sudifed or Triamic Night. Time just at night.  Dx with URI on 04/24. Still cough, congest and RN. Has seizures- more when he is sick- last couple days- having seizures. 06/27/2002 p.c. with mother- had 2 seizures last night . Has been more cranky since yesterday. Call allergy test until seen by neurologist faxed all work to MD. Spoke to dad- several seizures today. Wants to make sure everything is OK. P UC tonight.  06/27/2002 Screaming all day today, seizure last NOC and today. A febrile, decreased appetite.
Urticaria in arms and face 5 minutes following H1N1 2009 administration. No hives, no trouble breathing. Resolved following 50mg diphenhydramine IM in same deltoid.
Rash and red and slight pain on left arm first day day two rash spread to right leg..day three rash spread to back ?day four excruciating pain began in arm vaccine given and as days progressed range of motion became affected ..can not lift arm above chest level without extreme pain ..cannot reach behind back without extreme pain health department notified to see if these reactions normal after going on over a week or two they reported to go to pcp that these were not normal ..pcp ordered X-ray then Pt ..declined in pt which resulted in mri
I received the first in the series with no affects, and after several years received the second with no affects. On schedule I received the third at 9am on a friday morning- by 6pm I had a fever of 100 degrees. Despite taking tylenol (and then aspirin when I had taken 8 tylenol in 24 hours) my fever lasted for two days, getting up to 101.5. After my fever finally broke, I was very weak and had little balance. I drank lots of carrot juice, which seemed to help a little bit (Vitamin A is good for the liver) On Monday morning I was still without very good balance and weak.
After receiving her vaccine, client stated she has a metallic taste in her mouth.  Vital signs obtained.  BP 155/90, HR 75, O2 Sat 97.
Swollen itchy Rash on Left arm elbow has had for 3 days  When bitten by mosquito. When scrated by my cat Large red rash appeared on both hands and wrist. Rash was there for less than a day
The intended injection site of this Tdap was my left delt. When the nurse administering the vaccine stuck the needle in my shoulder the needle felt too superior/posterior and was not centered on my deltoid muscle. The initial injection felt fairly normal, but within 5-10 minutes my shoulder pain increased more than I expected. By that evening, I was having difficulty lifting my arm and was woken from sleep several times throughout the night with severe shoulder pain. I took ibuprofen repeatedly which did not improve the pain. The pain, weakness, and limited range of motion continued to worsen  until I returned to the same doctors office 1/27/2020 for a follow up. I saw a Nurse Practitioner who did a focused exam and determined I had some sort of AC joint irritation related to the vaccine. She prescribed prednisone and told me if the pain did not resolve I would have to consider joint injection and possibly an MRI. The prednisone improved the pain and range of motion over the next 10-14 days. I returned to the office for another check 2/18/2020 and saw my regular Primacy Care Physician. I believe the pain was resolved/close to resolved at that time.
Pt c/o nausea, loose stools, chills, feverish, body aches, dizziness, vertigo s/s, uncontrolled shaking and was unable to sleep related to s/s. Pt took Motrin on 12th. No redness noted. On 5/13/2010 seen by Dr. at 11:00 s/s remained with nausea & shaking increased on the 5-13-10.  Noted reddened mark however the redness was gone prior to leaving office. Pt took Benadryl & Motrin on the 13th in the afternoon. S/s resolved on 5-14-10.
Fever; chills; muscle aches; This is a spontaneous report from a contactable nurse. A 22-year-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EK9231), intramuscularly on 06Jan2021 at 18:30 at a single dose on the left arm for COVID-19 immunization in the hospital. The patient's medical history and concomitant medications were not reported.  The patient previously took spironolactone and had allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. On 07Jan2021 at 05:00, the patient experienced fever, chills, and muscle aches. No treatment was given to the patient. Since the vaccination, the patient has not been tested for COVID-19. The patient was not pregnant at the time of vaccination. The outcome of the events was recovered on an unspecified date in Jan2021. The events were considered non-serious.
Patient got 2nd dose of the moderna vaccine and within the 5mins, both ear felt clogged and could not hear. At night the day of the vaccine, the right side cleared and she was able to hear again. Left side still cannot hear.
PT COMPLAINED OF ITCHY WATERY EYES, AND COUGH LEADING TO DIFFICULTY BREATHING AND SEVERE HEADACHE - PT TOOK IBUPROFEN, THEN NORCO AND BENEDRYL AND SYMPTOMS RELIEVED - PT SAID SHE WAS STILL FEELING RUN DOWN 24 HOURS AFTER VACCINE.