chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Injection site pain; Tiredness; Muscle pain; Joint pain/weakness; Joint tightness; Chills; Loss of appetite; joint pain/weakness; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 22Apr2021 at 11:15 (at the age of 48-year-old) as a single dose for COVID-19 immunisation. Medical history included covid-19. The patient had no known allergies. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any other medications within two weeks of vaccination. On 23Apr2021 at 05:00 the patient experienced injection site pain, tiredness, muscle pain, joint pain/weakness, joint tightness, chills and loss of appetite. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19.  The clinical outcome of the events injection site pain, tiredness, muscle pain, joint pain/weakness, joint tightness, chills and loss of appetite was resolving at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Initially, just a sore arm and tiredness.  With the second dose, I had a temperature of 101 for a day and a half (no big deal).  Sometime after the first dose, I started a bad round of migraines.  Eventually, I had to go to the ER for IV medications to try and get it under control.  Also, my depression got worse and worse, to the point where I had to be hospitalized in the end of May.  I was discharged but ended up being readmitted about three weeks later.  This is among the worst episodes of depression I have ever had.  The migraines and depression may or may not be related to the shot.
flare of arthritis; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 30Dec2020 at single dose for COVID-19 immunization.  Medical history included arthritis from an unknown date and unknown if ongoing.  The patient's concomitant medications were not reported.  The patient received Covid-19 vaccine on 30Dec2020, then he had flare of arthritis in Dec2020 (have this before having the vaccine). Asked if take steroids will affect the Covid-19 vaccine. The outcome of the event was unknown. Information on the lot/batch number has been requested.
01/15/2021 - fever, fatigue, chills - ibuprofen taken about 7pm, fever reduced 01/15/2021 - large, red bump at injection site - nothing taken on that day - bump eventually receded to what looked like a bruise and did not hurt or itch about 01/20/2021 - large, red, warm bump (welt) with smaller bumps on top of welt returned at injection site and has persisted through 01/21/2021 and 01/22/2021 - 75 mg of Benadryl taken each evening with slight to no relief. Unable to take Benadryl during the day due to work.
Dizzy spells around 23 hours after the vaccine until about 27 hours after the vaccine; Sweats; chills from about 12 hours after the vaccine until about 36 hours after; This is a spontaneous report from a contactable consumer, the patient. A 36-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EC9265) via an unspecified route of administration in the right arm on 23Feb2021 at 14:00 (at the age of 36-year-old) as a single dose for COVID-19 immunisation. Medical history included asthma. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included birth control pill and montelukast sodium (SINGULAIR) for an unknown indication from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EC3249) via an unspecified route of administration in the right arm on 02Feb2021 at 14:00 (at the age of 36-year-old) as a single dose for COVID-19 immunisation. On 24Feb2021 at 02:00, the patient experienced sweats and chills from about 12 hours after the vaccine until about 36 hours after and on 24Feb2021 at 13:00, experienced dizzy spells around 23 hours after the vaccine until about 27 hours after the vaccine. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event dizzy spells was recovered on 24Feb2021 (about 27 hours after the vaccine) while the events sweats and chills were recovered on 25Feb2021 (about 36 hours after).   No follow-up attempts are needed. No further information is expected.
Right after I sat down in the waiting area after receiving the shot, I experienced racing heart and a flushed, slightly tingly feeling for about a minute. It passed and I have felt mostly normal for the rest of the day except tiredness and achy left arm.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 77-year-old male patient received BNT162b2 (BNT162B2), on 20Jan2021 at 11:00 as dose 1, single (Batch/Lot number: unknown), in left arm and on 10Feb2021 at 11:00 as dose 2, single (Batch/Lot number: unknown) at the age of 76 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), on 16Aug2021 at 12:00 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 22Apr2022 at 12:15 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Arrhythmia" (unspecified if ongoing). Concomitant medication(s) included: FLECAINIDE, start date: 04Nov2020, stop date: 30Jun2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "unknown" and all described as "COVID-19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: The patient's other medication in 2weeks product is Flecainide. The patient was taking any other medications/products within 2 weeks of starting COVID-19 treatment. The patient previously received a COVID-19 Vaccine. The patient Reported Event: Atrial fibrillation began about 10:00 am, 04Jul and has not stopped. I resumed flecainide 24 hours after stopping Paxlovid. The patient was Not recovered and treatment received for the reported AE: Flecainide restarted 07Jul. The patient did not have any known allergies. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Tired and sore; Tired and sore; shakes; sweating; diarrhea; TIired and slept most of Tuesday; aches and pains were more intense; Tired and slept most of tuesday; Fever of 101F, fever rose to 102 F; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 31-Mar-2021 and was forwarded to Moderna on 31-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (shakes), HYPERHIDROSIS (sweating), DIARRHOEA (diarrhea), PAIN (Tired and sore) and SOMNOLENCE (TIired and slept most of Tuesday) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048A21A and 011A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Sciatica and Arthroscopy (Orthoscopic surgery on knee). Concomitant products included NAPROXEN for an unknown indication.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Mar-2021, the patient experienced TREMOR (shakes), HYPERHIDROSIS (sweating), DIARRHOEA (diarrhea), SOMNOLENCE (TIired and slept most of Tuesday), PAIN IN EXTREMITY (aches and pains were more intense), FATIGUE (Tired and slept most of tuesday) and PYREXIA (Fever of 101F, fever rose to 102 F). On 31-Mar-2021, the patient experienced PAIN (Tired and sore) and FATIGUE (Tired and sore). On 30-Mar-2021, TREMOR (shakes), HYPERHIDROSIS (sweating), DIARRHOEA (diarrhea), SOMNOLENCE (TIired and slept most of Tuesday), PAIN IN EXTREMITY (aches and pains were more intense), FATIGUE (Tired and slept most of tuesday) and PYREXIA (Fever of 101F, fever rose to 102 F) had resolved. At the time of the report, PAIN (Tired and sore) and FATIGUE (Tired and sore) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Mar-2021, Body temperature: 101 f High and 102 f High.         Treatment using acetaminophen and naproxen was reported
developed sore throat  and emesis 4/13/21, sore throat continued and fevers developed 5/4/21, lab work was concerning for a rheumatological process, after which patient was diagnosed with SLE, lupus nephritis
This spontaneous report as received from a pharmacist refers to a 42 years old female patient. The patient had allergies to soy isoflavone and latex. On 13-OCT-2012 the patient was vaccinated in her left deltoid by intramuscular injection with a single dose of 0.5 ml PNEUMOVAX23 (lot # H010661, expiration date reported as 02-FEB-2014). Concomitant medications included FLUVIRIN (Novartis) and MENACTRA (Sanofi), both of which were vaccinated in the patient's right arm during the same visit, on 13-OCT-2012. The patient developed a case of cellulitis, described as "very large" and a fever described as "greater than 102 degrees Fahrenheit" at an unspecified time following vaccination. Pharmacist reported that this was the patient's third lifetime dose of PNEUMOVAX23 and the patient had experienced similar, though milder reactions following prior doses of PNEUMOVAX23 (lot # not reported). Pharmacist did not know the patient's prior medical history, but stated that the patient reported that her healthcare providers had urged her to get PNEUMOVAX23 every 5-10 years. The patient sought for unspecified medical attention. Antibiotics and oral steroids were given as treatment. Lab diagnostics studies performed were reported as none. The patient recovered on an unspecified date. Additional information has been requested.
After the 3 vaccine I blacked out and had a really bad fall and found all the items on the wall shelf on me. I was bruised and hurting. I woke up around 2:38 am, I must have hit the wall hard. I got up and got some water. I went to the doctor that Friday. And then went back on Monday because I was in pain. My Oncologist wanted to make sure the cancer didn't come back and spread. The CAT scan came back normal. The neurologist said that the black out were from seizures I was having. I was referred back to the endocrinologist and heart doctor. I haven't had anymore black outs since being put on the medication.
Moderna COVID?19 Vaccine About a day after I received the shot I had redness, soreness and swollen at the injection site, that went away about 2-3 days later.  Then about 8 days after the shot the redness and swollen came back in the same area it is also itchy
Night sweats, Cramps and numbness in the upper and lower extremities. Elevated pulse up to 122. Chest pains with punctures Hematomas in upper and lower extremities. Trigger fingers, Cloudy, dizziness.
Chill, fever, indigestion, nausea, lost taste, headache, dizzy, spine pain, super dry mouth, dry throat.
PASSED OUT; VERY HOT FEELING; SKIN WAS BURNING LIKE SEVERE SUNBURN ( ON WAIST, SHOULDER, ARM, HAND, BELLY, NECK, BREAST,  AND FACE); BODY DRAINED; SKIN REDNESS; GOOSE BUMPS; FEELING COLD; SCRATCHED BODY; HEADACHE; FELT LIKE FAINTING BUT DID NOT FAINT; This spontaneous report received from a patient concerned a 54 year old female. The patient's weight was 165 pounds, and height was 154.94 centimeters. The patient's concurrent conditions included high blood pressure, diabetes, penicillin allergy, nonsmoker, and non-alcohol user. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980,expiry: 20-JUN-2021) .5 ml, administered on 30-MAR-2021 to the left arm for prophylactic vaccination. No concomitant medications were reported. On 30-MAR-2021, the patient experienced dizziness (felt like fainting but did not faint). Then 15 minutes later, she was fine. On 31-MAR-2021, the patient experienced headache. On 03-APR-2021, three hours into the work, she felt very very hot and her skin was burning like severe sunburn. It was waist, shoulder, arm, hand, belly, neck, breast, and face were hot and red. She scratched the body and was really warm and skin was really red. After 40 min, the patient's body went to back to normal. After 5 min, patient started feeling really cold and goose bumps on her arms that lasted for 30 minutes. After that episode she went home and felt her body was drained and passed out. The patient felt better on 04-APR-2021.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from passed out on 04-APR-2021, very hot feeling, skin was burning like severe sunburn ( on waist, shoulder, arm, hand, belly, neck, breast, and face), body drained, skin redness, goose bumps, feeling cold, and scratched body on 03-APR-2021, and felt like fainting but did not faint on 30-MAR-2021, and was recovering from headache. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210430845-covid-19 vaccine ad26.cov2.s-Passed out. -This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Moderna first vaccine shot. Red, swollen, slightly painful at injection site. Swollen lymph nodes in left armpit.
Hospital Course:  79 year old female was admitted for Covid-19 infection and worsening renal function from dehydration. She was treated with IV fluids and Remdesivir. Renal function improved. She will be given the thrid dose of Remdesivir today and discharged afterwards. Patient educated on appropriate level of care post-discharge. Follow up with Primary Care Doctor in 5-7 days.   Physical Exam on the day of discharge: Last Recorded Vital Signs: Temp: 98 °F (36.7 °C) Pulse: 77 BP: 152/61 Respirations: 18 SpO2: 96 % O2 Flow Rate (l/min): 0 l/min General Appearance: no distress  Eyes: PERRLA ENT: moist mucus membranes, no adenopathy Lungs: clear to auscultation bilaterally  Heart: regular rate and rhythm Abdomen: soft, non-tender Skin: No rashes or lesions  Extremities: full ROM Neuro: alert, normal strength and tone     Significant Diagnostic Studies:   VQ scan, BLE venous US   Operations: none   Disposition:  Home    Discharge Condition:  Fair
PATIENT CAME IN TO SHOW ME REACTION.  INJECTION GIVEN IN LEFT DELTOID.  INSIDE AREA OF  LEFT ELBOW SWOLLEN/DISCOLORED/SMALL BLISTER.  SHE SAYS AREA WAS MUCH WORSE YESTERDAY & FEELS IT IS GETTING BETTER.  SHE IS NOT WORRIED ABOUT IT, BUT I TOLD HER TO BE SURE TO CALL HER DOCTOR IF IT WAS NOT SIGNIFICANTLY BETTER TOMORROW.  AREA IS SWOLLEN & DARK RED/BROWN IN COLOR.
PT CALLED  AFTER GETTING THE VACCINE THAT MORNING. SHE HAD HIVES AND THROAT STARTED TO SWELL
Information has been received form the pregnancy registry for GARDASIL from a 20 year old female patient, with no known pertinent medical history and no drug reactions/allergies, who on 14-JUL-2008 was vaccinated with the first dose of GARDASIL (Lot # 655604/0052X). There was no concomitant therapy. The health care worker reported that on 04-AUG-2008, the patient had a positive pregnancy test. The patient sought medical attention at physician's office. The last menstrual period was on 06-JUL-2008. Estimated date of delivery approximately 12-APR-2009. At the time of the report the pregnancy was normal. Follow up information was received from a health care worker which reported that the patient had a medical history of genital condyloma, who on 14-JUL-2008, was vaccinated with the first dose of GARDASIL (Lot # 9725103). The health care worker reported that the last menstrual period was on 05-JUL-2008. Estimated date of delivery approximately 10-APR-2009. On 16-JUL-2008, the patient was treated with metrogel and vaginal gel at bedtime for gardnerella vaginalis. Additional information has been requested.
This spontaneous report as received from a registered nurse refers to multiple patients of unknown age and gender. On an unknown date the patients were vaccinated with PROQUAD (Merck) lot # K022445, with expiry date 13-MAY-2016 and lot # L013545, with expiry date 17-OCT-2015, that was improperly stored. No other adverse effects were reported. The outcome of the improper storage of vaccine was not known. This is one of the two reports received from the same source. Additional information has been requested.
Urinary Track Infection and bleeding like menstrual bleeding for 3 weeks straight starting 2 weeks after 1st vaccine.
After I received the vaccine, I took a few days off (I am a long-distance runner) and then noticed my lungs became restricted when I was running. I had shortness of breath. Even walking uphill was beginning to be too much. I was also wheezing. At first, I wasn't coughing but after the vaccine I began coughing after running. I saw my doctor on May 18th and was told that it was exercise induced asthma from the cold I had in the end of February. I was prescribed albuterol, I used it before exercise, and it has helped with my symptoms. It did not alleviate all symptoms but did make it so I felt like I could breathe easier.
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 08-MAR-2018, the patient was vaccinated with GARDASIL 9 lot number N021475 with expiration date on 31-JAN-2020 (strength, dose, route of administration and anatomical location were not reported) for prophylaxis. The administered dose of the vaccine experienced a temperature excursion in the range between 32°F up to 35°F for 270 minutes and 47°F to 77°F for 75 minutes, as recorded by a data logger. The vaccine had not had any previous temperature excursions.  There was no adverse effect reported. No product quality complaint was involved. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1805USA003078:
Pt has on (R) thigh 2.25"X 1.75" raised red area on (L) thigh 1.75"X1.5" raised red area was seen by Dr given rx for AUGMENTIN.
Patient contracted COVID after being fully vaccinated Loss of smell, congestion, sore throat, fever, cough, muscle aches.
He got his vaccine, didn't have any reaction.  He was told to take his temp for a couple of days, but no reaction.  His legs went out from underneath him, fell onto his cough as he was walking through the ER.  His sons took him to the ER and he was put in a waiting room sitting in a wheelchair for about 3 hours.  When he was seen the doctor asked what was wrong, and he told him to prove it to him.  The doctor put a walker in front of him to stand up, and told him that he couldn't stand up.  The doctor had a nurse pull him up, did not lock the bed down and the bed collapsed underneath him, and smashed his hard on the ground, and broke his glasses.  They kept him for 3 days and did 6 CAT Scans and 6 MRIs on his brain and said that he had a mild brain bled.  He was then put on Eliquis twice a day.  He is to go back to 3/2/23 to have tests run again.    One of the nurses he heard talking and said that he had a subdural hematoma due to him being dropped on his head.  He could not walk due to him having a stroke. He has real limited use of his left hand, and is in a hospital bed.  He has had home health to help him walk, and he had to walk with a walker and they follow him in a wheelchair as he tends to fall backwards.  The PT thought by last year he would be OK, and he quit coming as his insurance wouldn't pay for him, and now he has gone backwards in his recovery and now his family has to do the PT and he can only do about half as much.   He also had to wear a catheter up until a month and a half ago.  He told them that he could not take it anymore and was deflated.  He does not have control of his bladder yet, but it is getting better.   He was not able to sit up at first, and has lost a lot of weight and had to buy a special toilet to be able to stay on it.  He has been gaining some weight back.  He has to have assistance to get on and off of the bathroom and other duties.    He went to the Hospital.
Medical Assistant gave this patient a booster dose of the Pfizer vaccine today. She did not realize that the vial had not been reconstituted yet, and gave him the vaccine without being reconstituted.
I got my first shot today should I be short breath; I got my first shot today should I be tired; This spontaneous case was reported by a patient and describes the occurrence of DYSPNOEA (I got my first shot today should I be short breath) and FATIGUE (I got my first shot today should I be tired) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DYSPNOEA (I got my first shot today should I be short breath) and FATIGUE (I got my first shot today should I be tired). At the time of the report, DYSPNOEA (I got my first shot today should I be short breath) and FATIGUE (I got my first shot today should I be tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication information provided.  No treatment information provided
Patient reports with round, red rash about 3 inches wide and 3 inches high around deltoid area of injection site. It is slightly warm to touch and she states it is mildly itchy but otherwise no symptoms just redness. Recommended patient monitor at home and report to PCP for follow up.
Abdominal pain, vomiting, diarrhea, burning sensation in back and arms, clammy, chills, weak legs from about 4AM until 5:30 AM and then went to sleep. Woke up at 8:30AM and felt better
nausea, emesis;rt thigh erythema & edema;fever-no temp taken by mom 99.9 in office 12AUG98;