chrisvoncsefalvay/vaers-outcomes huggingface dataset:
1st dose given 2/18/21, 2nd dose given 3/3/21, 3rd dose given 11/9/21. All MODERNA
Day 1 - Sore arm resolved 4 days after Day 2: Itchy rash, still ongoing 4 days after. Headache, body ache, skin sensitivity, lasting one day.
this is 1 of 4 hospital employees to exp hypotension w/nausea, dizziness, shakiness, weakness, & flushing immed p/vax;
Golf-sized, reddened and warm area noted to injection site. Area tender to touch and with ROM.
Pt. admitted to hospital following possible seizure on 7/12/11. Pt. had fever noted by parents of 105.5 prior.
Information has been received from a physician concerning a female who on an unknown date was vaccinated with GARDASIL vaccine (yeast). On an unspecified date the patient developed hives. The physician did discontinue the series. Subsequently, the patient recovered. The patient sought medical attention. No further information is available.
Ran a fever the following night + sore muscles + bones (felt like a case of the flu) for 1 1/2 days. Still - after 2 1/2 months - having tingling on the left arm. Feels like "ants crawling" + the blood running up + down the veins in left arm. At night, the feeling of a "rolling pin" moving up + down the arm awoken me. The vein in the elbow is raised when the tingling occurs. The "sensation" happens multiple times each day, sometimes 2 or 3 times in an hour. From 8/21 to 11/6 Still feeling tingling sensation on the left arm
1 day after dose 1: rash on left side of torso, hot to touch left arm, overly tired, fatigue, headache, bone and joint ache for 3 days after dose 1. Then repetitive rashes from dose 1, dose 2, to present- appears to be petechia on left hip,
mom of child reported approx 4-5hr p/vax pt had rash on back & shoulders since vax & was exp inconsolable crying;instructed to take pt to pediatrician ASAP;
"MOC states bled & was bruised @ time of shot;that evening a large rash was noted on rt arm @ site of tetanus shot, area red, hot inflamed;PMD ordered keflex & compress to area;MD dx as cellulitis w/swollen lymph foods"
5/14/21 Sore and tender arm, overnight fever and chills, nauseous, body aches and pain especially neck, back, and hips. 5/15/21 Continued fever symptoms, throbbing headache, nearly passed out, light headed upon transitions from supine to sit or sit to stand. Fatigue and lethargy. Excedrine after nausea resolved decreased other symptoms somewhat. 5/16/21 Poor temperature regulation i.e. hot then cold all day, continued light headedness upon standing, less body aches, no longer nauseous but gassy with loose stools. 5/16-5/18/21 Warmth and swelling, mild redness and skin texture change right arm 1-2 inches distal to injection site, intermittent itching. Gradually decreased until resolved. 5/19/21 Mildly sore throat right side. All symptoms seem resolved by reporting date of 5/24/21.
J96.11 CHRONIC HYPOXEMIC RESPIRATORY FAILURE 6/14/2022 HX OF ACUTE KIDNEY INJURY R09.02 HYPOXIA 10/18/2021 HX OF ACUTE KIDNEY INJURY J96.11 CHRONIC HYPOXEMIC RESPIRATORY FAILURE 6/14/2022 MAJOR DEPRESSIVE DISORDER, RECURRENT EPISODE, MODERATE R09.02 HYPOXIA 10/18/2021 MAJOR DEPRESSIVE DISORDER, RECURRENT EPISODE, MODERATE J96.11 CHRONIC HYPOXEMIC RESPIRATORY FAILURE 6/14/2022 HYPOGLYCEMIA R09.02 HYPOXIA 10/18/2021 HYPOGLYCEMIA
He woke up from his nap covered on his stomach and face with tiny red bumps. He was very fussy and we called after hour clinic that evening and they said bug bites possibly by our description.  By late evening he had huge hives covering his entire body and head.  Took him to doctor the next day and they said it had to be the shot.  Went back the next week for checkup and (the hives were still out of control) they claimed we couldn't know for sure it was the shot.  He had hives that lasted 2 months.  The first month they covered him head to toe.  The second month, they lessened and he only broke out when he would get upset, get too hot, etc.  The first couple of weeks we were told to watch him 24 hrs a day to make sure swelling didn't begin internally and breathing stop.  That never happened, thank goodness. He screamed....a lot in pain.  Main symptoms major hives, screaming, sleeplessness, discomfort.
Still painful 2 1/2 weeks later. Like having overnight arthritis; 48 hours after vaccine, both hands began to ache slightly and be painful to use; Still painful 2 1/2 weeks later. Like having overnight arthritis; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A 66-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EN6198), via an unspecified route of administration (at the age of 66-years), administered in arm right on 23Feb2021 at 10:45 as dose 1, single for COVID-19 immunization. Medical history included anxiety from an unknown date and un-known if ongoing. Concomitant medications included escitalopram oxalate (LEXAPRO), rosuvastatin calcium (CRESTOR) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccine in four weeks. Patient does not have covid prior vaccination and has not been tested for covid post vaccination. The facility type vaccine was reported as other. On 25Feb2021 at 10:00, the patient experienced still painful 2 1/2 weeks later. like having overnight arthritis, 48 hours after vaccine, both hands began to ache slightly and be painful to use. The treatment was received for all the adverse events. The patient was taking Ibuprofin (no more than 2 per day). The clinical outcome for all the events was reported as not recovered.  No follow-up attempts are possible; no further information are expected.
With both doses I had high fever, chills, nausea, vomiting, headache, body aches lasting three days. I also urinated blood for three days. My creatinine levels more than doubled from last taken date of 11/2019 and my GFR was very high.  When this happened with the second dose my doctor ordered a CT  scan and sent me to a Nephrologist, who ordered a kidney biopsy.
PATIENT WAS GIVEN THE COVID-19 PFIZER VACCINE @11:18AM. THEY WERE ASKED TO STAY 15 MINUTES AT THE WAITING AREA AND AROUND 11:21AM, HE FAINTED. I RAN TO THE PATIENT, HE WAS ALREADY CONSCIOUS BUT STILL CALLED 911. PARAMEDICS CAME 15 MINUTES LATER, HE WAS ALMOST RELEASED TO GO HOME BUT UPON STANDING UP, HE FAINTED AGAIN. HE WAS TAKEN TO HOSPITAL AND WAS DISCHARGED SAME DAY.
Headache  Very  Bad  --  Left  Arm  pain  in  Arm  and  around  Left  sholder  --  Upset  Stomach  --    Tongling  in  Tips  of  fingers  and  also  Toes  --  My  whole  Body  Ached  --  and  I  was  in  Bed  for  2 Days  --    It  has  been  10  Days  and  I  am  still   NOT  Back  to  normal  --    And  I went  to  see  my  DR.  on   12/6/21   --  I    was  Feeling  FINE  befor  I  had  this  Booster  shot  --
Patient developed a red area around injection site 2x1" in size per Dr-prescription written for Keflex
Pt fainted during vaccine administration.  Recovered within 30 seconds.  Ice pack to back of neck. Fruit juice provided.
Per patient: had a normal reaction during the first 4 days including sweats, chills, body aches, and fever.  On day 5, patient reported have facial numbness and swelling effecting half the face. Went to the hospital and noted that numbness spread to the entire face. Was sent home after 12 hours. On day 6, he reported swelling of extremities (hands/feet) and returned to the hospital. He said he was given epinephrine at the hospital.
Patient was admitted with acute renal failure, kidney biopsy showed Banff III TCMR in transplanted kidney. He is just over a year post kidney transplant. Patient got J&J 2nd vaccine on 16th and symptom of hematuria started on 11/17/21. Had received 1st dose in 3/2021 without any issues. Notably, one of his immunosuppression meds (cellcept) dose was reduced to 250mg BID recently for BKV viremia. There was no evidence of BKV in kidney biopsy.  He had several triggers for rejection including CMV viremia few months back, BKV viremia, slightly decreased cellcept dose. But given temporal relation with vaccination with J&J, and the resultant severity of the rejection despite being on 2 other immunosuppression agents at good doses and no preceding DSA, raises the concern of if the vaccine had any role to play in triggering his immune system facilitating this degree of rejection. He is being treated for TCMR at this time.
Within a few hours of vaccine I began feeling tired, lightheaded, chilled. The next day the fatigue continued, followed by nausea,headache, low grade fever, chills, muscle pain. By the following day I woke up with a rash on my torso, all other side effects were gone. Rash was gone the next day, to this date, six days later, some itchiness persists where rash was. In particular at night while in bed.
mom reports child hat bilat leg swelling & 3hr of inconsolable shrieking & crying p/vax;
Arm swelling at site of injection, hot, itchy, and hard lump on arm. Feels like a hard, large rock in arm.
Erythemotous, blotchy, apparently intradermal eruption axillae, trunk, face; some 1cm, raised macules.
Muscle and joint ache, insomnia, headache, upset stomach, nausea, vomiting, foggy-head
When getting both doses of the vaccine I had to be off of work for a week. Starting 6 weeks later I got put off work and am still off figuring out what is going on. It has been 6 months. It started with really bad dizziness and sickness upon vaccine. Soon after came the brain fog, muscle spasms, balance issues weakness and a list too long to type right now. All they have found so far is I have some type of auto immune issue. I'm still undergoing testing to figure out what the issue is. It correlates with the vaccine. Whether it was something underlying it brought out or something it caused.
Admitted to hospital- Acute severe progressive hypoxic respiratory failure- intubated, trach placed, COVID-19 pneumonia, Afib Patient treated at primary care office 01/13/2021 for respiratory illness (tested negative for COVID at this time), had vaccine 01/20/2021, developed headache and tested positive COVID-19 the following day 01/21/2021. Symptoms worsened with nausea and shortness of breath. Patient admitted 01/29/2021, condition progressed- intubated 02/07/2021, trach placed 02/25/2021.Discharged to specialty hospital 03/12/2021 for continued respiratory support and rehabilitation
Muscle weakness and ache, especially in legs; slight feeling of nausea, tiredness at times; entire body felt like the body feeling of flue, although there were no headaches; no cough, no breathing problems. I didn't take anything. Reduced food intake, nothing complex.
Facial paralysis, confirmed by PTP and neurologist, Dx Bell's Palsy, prescribed oral corticosteroids and anti-viral.
Pain and swelling in the axillary area.  Tylenol used for pain, no relief.  Symptoms started sometime yesterday (4/7/21) and have not improved.
I have chills, fever,muscle aches and what feels the worst is the nauseau, like I want to throw up. It was hard to enter this online note. I just missed the phone hours. I am tired and arm hurts to raise it. I want to sleep and maybe throw-up. It is hard to complete forms and no energy to read the detailed instructions. Both shots were given at the clinic. I also have a mild right sided back painthoracic mild muscle spasm. Harder to concentrate at work.
Information has been received from a certified medical assistant concerning unspecified patients who on an unspecified date were vaccinated with hepatitis B virus vaccine rHBsAg that stored at colder than recommended temperatures. No adverse symptoms noted. It was unknown if the patients had sought medical attention. 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. This is one of several reports received from the same source. All telephone attempts to obtain follow-up information have been unsuccessful. Additional information has been requested.
Large area of redness at injection site, pain at injection site, and a hard spot at the injection site.  Area is still red and hard spot is still there as of 8/1/16 at 140pm.  Pain resolved on Saturday 7/30/16.  No treatment provided.
Pt started getting symptoms within a few hours. The symptoms she reported were: nausea, H/A, dizziness, joint pain, fever, chills, cramping/sore muscles, and her whole deltoid area was red and hot. She finally was feeling a little bit better on Saturday, so she came into the store and reported this to me. Her deltoid was still slightly red, but had faded and was no longer hot - clearly outlined area.
This spontaneous report was received from a vendor and refers to a patient of unknown age and gender. No information about the patient's pertinent medical history, concomitant medications and drug reactions or allergies was reported. On 09-MAY-2016, the patient was vaccinated with an expired dose of VAQTA injection, expiry date January 2016 (dose, route of administration, lot # and administration site were not specified). No adverse effects were reported. Product quality complaint (PQC) was not involved. The reporter stated that a healthcare professional from the physician's office at which this occurred would call to follow up and provide contact details of an appropriate healthcare professional to whom follow-up correspondence might be sent. Additional information has been requested.
pt first experience soreness and took ibuprofen.  then rash redness and was advised by a different rph to apply cortisone. Yesterday pt is running temperature, fire red skin from site on injection down arm past the elbow. fluid in elbow per md.  sore and painful
COVID 19 Treatment; COVID 19 Treatment; his is a spontaneous report received from a contactable reporter(s) (Physician) from product quality group. The reporter is the patient.  A 66-year-old male patient received BNT162b2 (BNT162B2), on 29Dec2020 as dose 1, single (Lot number: EKS730), in left arm, on 20Jan2021 as dose 2, single (Lot number: EL3246), in left arm and on 01Aug2021 as dose 3 (booster), single (Lot number: EW0198) at the age of 65 years, in left arm for covid-19 immunisation; janssen coviD-19 vaccine (JANSSEN COVID-19 VACCINE), on 11Jan2022 as dose 4 (booster), single (Lot number: 1855190), in left arm for covid-19 immunisation. The patient's relevant medical history included: "hyperlipidemia" (unspecified if ongoing); "NAFLD" (unspecified if ongoing); "hairy cell leukemia" (unspecified if ongoing); "CAD" (unspecified if ongoing). Concomitant medication(s) included: ROSUVASTATIN, start date: Jan2015 taken in 2 weeks. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: COVID 19 Treatment; (26Jul2022) Positive, notes: positive rapid Covid test again 26Jul. Therapeutic measures were taken as a result of vaccination failure, covid-19. Treatment included Paxlovid from 14Jul2022 to 18Jul2022.  Clinical course: No known allergies were reported. Rebound Covid infection (completed 5d of Paxlovid 18Jul, symptoms came back on 24Jul, positive rapid Covid test was performed again on 26Jul symptoms persist but no evidence of severe disease at present.; Sender's Comments: Based on available information a contributory role of BNT162B2 to the reported events Covid-19 and vaccination failure cannot be totally excluded as efficacy of a drug varies from individual to individual depending upon the immune status. As with any vaccine, vaccination with BNT162B2 may not protect all vaccine recipients, so the expectedness of covid-19 and vaccination failure  is : expected. The case will be reassessed further upon receipt of additional information.
The night of receiving the vaccine I experienced an involuntary convulsion at the onset of sleep.  As this reminded me of a previous experience when I expect I experienced COVID  I was afraid and fought hard to stay awake.  However, I drifted off to sleep a second time and immediately experienced another convulsion.  I stayed awake deliberately all night.  Another night I awoke with a racing heartbeat.  Again, a repeat of a previous experience approximately 1 year ago.  Yet, another night I awoke and my arm was numb from shoulder to fingers. Also, a repeat of a prior experience.  However, other than the fear these repeat experiences aroused I have had no other considerable effects.  I am not sure if these experiences classify as adverse events  but they did concern me sufficiently to submit for review and I have slight trepidation about taking the second dose.  I have a teaching credential and I believe I need it if I wish to work in the school system. Thank you!
pt called stating her arm has a red spot (mildly swollen) with symptom of itch where vaccine was given on 1/8/22.
Vasovagal reaction, sweats.  Pt. states she didn't have anything to eat.
I contracted COVID-19 over the holidays. I had really mild symptoms, some coughing and a minor headache. I completed an at home COVID-19 and it was positive. I called my doctor, and they advised me to go to an urgent care to see if I qualified Paxlovid. At this appointment they saw my heart was out of rhythm and sent me to the ER. They confirmed my heart was out of rhythm with an EKG. I was admitted for observation for 2 days. During that time, I was placed on a blood thinner. I was never put on Paxlovid for my symptoms.  and at that time it was discovered that my heart was out of rhythm. Later I had to have a cardiac aversion to put my heart back in rhythm. I had Cardioversion to return my heart to normal rhythm. My heart has remained in rhythm since. My hearts in rhythm but I have to remain on the blood thinners.
31MAR95 3PM became lifeless was sponged w/cold water & was transported to ER by amb had sz in amb-on arrival to ER t102.9; MD dx ear infect & started ATB & fever control med discharged home; family called clinic to report adverse rxn;
This case was reported by a other health professional via call center representative and described the occurrence of headache in a adult female patient who received SHINGRIX for prophylaxis. On 21st August 2018, the patient received SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced headache and vertigo. On an unknown date, the outcome of the headache and vertigo were not recovered/not resolved. It was unknown if the reporter considered the headache and vertigo to be related to SHINGRIX. Additional information was reported as follows: The age at vaccination was not reported. The patient experienced headache, experienced in front and back of the head, after vaccination with SHINGRIX. The pharmacy technician was reluctant to give out specific information about patient without their permission.
Received the first dose of Moderna vaccine at 11 a.m. March 15. About 8 p.m. March 15 started feeling tired with chills. About midnight March 16 severe chills, restlessness, headache, muscle aches, nauseous and fever of 101.  Took two extra-strength Tylenol. 3 a.m. fever broke with sweats. Headache and body ache remained, as did chills. Took two Advil when I woke up about 7 a.m. on  March 16 for a headache. But I was too tired and achy to get out of bed. The fever came back to 102 degrees. Nauseous, couldn't eat much. Headache. At 2:30 p.m. on March 16, I felt better...  I was very tired the night of March 16 and still had a minor headache and went to bed about  8 p.m. On March 17, I was back to normal with only a very minor headache and some diahreaha that morning and afternoon.  I did not take any medicine that day. On March 18 I had no symptoms at all. I am a very healthy 42-year-old adult. I would classify my reaction as significant, but not severe. I called in sick to work (and I work from home). So it was enough to take me out of a day.
muscles are weak; holding on to things in order to walk; She is also experiencing being able to feel when urinating and not being able to feel when she numbered two.; slurred speech; tired; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (tired), MUSCULAR WEAKNESS (muscles are weak), GAIT DISTURBANCE (holding on to things in order to walk), FEELING ABNORMAL (She is also experiencing being able to feel when urinating and not being able to feel when she numbered two.) and DYSARTHRIA (slurred speech) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) and MAGNESIUM for an unknown indication.    On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Apr-2021, the patient experienced FATIGUE (tired). On 29-Apr-2021, the patient experienced MUSCULAR WEAKNESS (muscles are weak), GAIT DISTURBANCE (holding on to things in order to walk), FEELING ABNORMAL (She is also experiencing being able to feel when urinating and not being able to feel when she numbered two.) and DYSARTHRIA (slurred speech). At the time of the report, FATIGUE (tired), MUSCULAR WEAKNESS (muscles are weak), GAIT DISTURBANCE (holding on to things in order to walk), FEELING ABNORMAL (She is also experiencing being able to feel when urinating and not being able to feel when she numbered two.) and DYSARTHRIA (slurred speech) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient has undergone 10-15 back massages as treatment.   This case was linked to MOD21-084005 (E2B Linked Report).; Sender's Comments:  MOD21-084005:
Patient received Hep B vaccine on Friday 05/09/2003.  That evening, Saturday, Sunday and Monday she experienced episodes of pain and numbness in the arm in which the vaccine was given.  With the pain she would also experience nausea and feel cold and clammy.  The school nurse instructed her mother to take her to her health care provider; however, the patient did not go.  Patient was ok on Tuesday 05/13/2003.
APPROXIMATELY 5 MINUTES AFTER RECEIVING SHOT, PATIENT WAS SITTING IN A CHAIR AND FAINTED ONTO THE FLOOR. WE SAW HIM IMMEDIATELY AND RESPONDED. HE WAS VISIBLY BREATHING AND SOUNDED LIKE HE WAS SNORING AND AFTER ABOUT 20-30 SECONDS HE WOKE UP AND SAID, "OH, DID I PASS OUT?" HE THEN EXPLAINED THAT THIS HAS HAPPENED TO HIM SEVERAL TIMES BEFORE, BUT NOT IN RECENT YEARS. HE HAD ANSWERED "NO" ON HIS QUESTIONNAIRE TO THE QUESTION ABOUT PREVIOUSLY FAINTING AFTER A VACCINE. HE SAT FOR A FEW MORE MINUTES, AND THEN LEFT STATING HE WAS FINE.
a patient got 1st dose of GARDASIL 9 in October 2017. Patient missed the 2nd dose.; No additional AE reported; This spontaneous report was received from a physician, referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.  In October 2017, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, route, lot# and expiration date were not reported) for prophylaxis.  On an unknown date, the patient missed the second dose. No additional AE reported.