chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 82-year-old male patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included hypertension and hyperlipidemia. Concomitant products included LIPITOR, Losartan and metoprolol. On 22nd June 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In June 2018, less than a week after receiving SHINGRIX, the patient experienced injection site tenderness. On 23rd June 2018, the patient experienced injection site erythema and injection site swelling. On an unknown date, the outcome of the injection site erythema and injection site swelling were recovered/resolved and the outcome of the injection site tenderness was recovering/resolving. The reporter considered the injection site erythema, injection site tenderness and injection site swelling to be probably related to SHINGRIX. Additional details were provided as follows: One day after receiving SHINGRIX, the patient experienced injection site erythema and injection site swelling. In June 2018, the injection site erythema and injection site swelling were resolved. The patient had denied permission to contact their physician.
Sore arm; chills could not get warm; Fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), CHILLS (chills could not get warm) and PYREXIA (Fever) in a 66-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm), CHILLS (chills could not get warm) and PYREXIA (Fever). At the time of the report, PAIN IN EXTREMITY (Sore arm), CHILLS (chills could not get warm) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Within 10 minutes - tingling in head, then very dry throat that became sore throat, nauseousness that led to throwing up. Trembling - (severely) then painful muscles (legs, etc). Very painful night - by morning all was gone - just exhausted. Duration - 15-16 hours.
Redness and lump at the injection site lasting for 6 weeks, 10/17/13 afternoon low grade fever 100.6 degrees, restless sleep/inability to sleep and irritablility for 4 days following.
He got his vaccine, immediately had dizziness.  Within 30 minutes could not move real good due to the Parkinson's.  He got more confused, more dizzy, and worsening of his Parkinson's.   He was very thirsty and drank a lot of water (4 liters of bottled water).  He was then urinating and sweating a lot as a way of his body trying to get rid of something in his body.  He was urinating more than he normally does.  He started getting harder for him to breath.  He noticed he had a bad taste in his mouth similar to when he had the COVID virus.  He got a horrible splitting headache/migraine type that kept coming and going.  He still has the taste in his mouth, and it affected the taste of food.  These were all symptoms similar to when he had COVID.  The headache was worse than when he had the virus.  No appetite still, but still continuing to drink the water and not urinating like you did the first day and a half.  He is not having to drink as much as he did before and not feeling like he was dehydrating.  Does have the soreness from the vaccine or any rashes. He did have chills and low grade fever of about 100-101, which have resolved.  He also had a sore throat which he still has.   He had a very bad case of the COVID virus 3/1/21, which lasted for a week or two.  He still has some residual symptoms from the virus with balancing/dizziness or worsening of his Parkinson's disease.  His neurologist told him that he would recover from the cognitive effects from the COVID with his Parkinson's, but his motor skills may not return.
Patient developed papular, Postula rash, centripetal, over face, over extremities, palm and one lesion o hard palate with some crusting and scabs. Erythematory lesions 3 to 6 mm sized. All scaling. Rash developed day 2 after vaccination of booster.
spasms, pain in torso area, has effected my urine and bowel movements.
VACCINE ADMINISTRATION ERROR: PATIENT RECEIVED VACCINE AT AGE 17, BUT APPROVED USE IS FOR 18 AND OVER. MODERNA ADVISES TO CONTINUE 2ND VACCINATION SCHEDULE/DOSE AS PLANNED, 4 WEEKS PAST 1ST DOSE.
Dizzy; Weak; Not feeling well; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41 year-old female patient received bnt162b2 (BNT162B2), administration date 10Mar2021 (Batch/Lot number: unknown) at the age of 41 years as 1st dose, single. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DIZZINESS (non-serious), outcome "not recovered", described as "Dizzy"; ASTHENIA (non-serious), outcome "not recovered", described as "Weak"; MALAISE (non-serious), outcome "not recovered", described as "Not feeling well". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of dizziness, asthenia, malaise.  Additional Information : Patient had an immediate reaction and currently still having reactions almost it was like side effects. Patient had it on Tuesday morning and still was dizzy, weak, just like not feeling well, so patient just recently get off the phone and insurance, like trying to get the nurse on the line and talk to primary care doctor, this number was in the packet that they sent me through, so patient calling all the numbers. Consumer was informed about the Role of Pfizer Drug Safety. Patient reported that patient thought patient was about 250 pounds. When probed for dose, Patient reported that was patient's first shot. When probed for route of administration, Patient reported patient received the shot in arm. When probed for any concomitant medication, Patient reported he took his prescription medicine that was it. The patient talked to primary care doctor, she told to take Tylenol and Benadryl, so patient need to go get that. Patient reported , patient did not have the card. Patient just realized that once patient got the shot usually they have to call 'EMF', so when the 'EMF' came over and the person have all our information, it was in the folder that they had taken from Wednesday from worksheet.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient received Moderna on 07/14/2021& 08/13/20212, then received Pfizer as booster on 10/05/2021.  No side effects reported at this time.
I was on travel and in a hotel Friday early morning I passed out in my hotel room and woke up with right sided numbness. Transported to ED at Medical Center and evaluated for stroke, pulmonary embolism and both were negative. Troponin levels showed I had heart damage and was given an ECHO/EKG and diagnosed with a Non-ST-Elevation Myocardial Infarction (NSTEMI). ECHO was inconclusive but shows left ventricle is mildly dilated with ejection fraction around 45% (taking into account limitations due to non-contrast and limited visualization. I am currently undergoing follow-up tests including a heart monitor for two weeks (ends 8/22), a stress test and ECHO cardio with contrast (9/8/22), and referred to a neurologist (9/26/22)
Right eye couldn't focus, horrible headache, asthma attack/panic attack, trouble walking with right side (all on day of shot couple hours after shot), fever and chills overnight, Friday: lip pain, headache continue, trouble walking/pain in legs continue through Saturday.
high pitched crying & low grade fever (100.6) vax administered 3PM; crying episode 5PM 1/2 hr duration; 3AM 1 1/2 hr duration unresponsive 1/2 hr; 5AM 1/2 hr duration; next noc 11Pm 1/2 hr duration;
Began with extreme fatigue. Within a couple of hours developed shortness of breath walking up stairs (never an issue prior) and palpitations. 01/26-walked to my gyno appointment two blocks away. After 20 minutes of rest had elevated blood pressure of 148/90, never had an issue w/ blood pressure. Woke up everyday with palpitations, shortness of breath and a headache that would last 10-15 minutes (not similar to any of my previous migraines). My palpitations and shortness of breath worsened over time and I started to feel them while lying flat or even slight movements such as standing up. My fatigue was pretty unbearable. I would need to take several naps a day and even then I never felt fully rested. I received my 2nd dose 02/27 and my symptoms increased in frequency and intensity. I was having more episodes a day and even walking within my own home I was out of breath. I went to the hospital and they were not able to find a cause for immediate danger so I was sent home. Originally they thought possible autoimmune issue such as Rheumatoid arthritis or lupus (prior to my RF, C-proteins and sedimentation rate results). My symptoms worsened from that visit; I began experiencing episodes of light headedness, brain fog, almost loss of consciousness, numbness in hands, muscle weakness, joint pain in knee, ankles and wrists. I am at a point now where even talking I can get out of breath or while showering I have difficulty breathing. Recently my brain fogs have become more frequent and noticeable. I have started seeing a cardiologist and am getting echo, exercise test and had a halter monitor placed, but still waiting on the results. During that visit the cardiologist noticed a slight aortic murmur, which was not present prior to this situation  This is has been completely debilitating to the point where I am on temporary leave from medical school.
Initial information received on 29-Oct-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves Adult patient who experienced high fever, while he/she received vaccine ADULT TENIVAC. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect ADULT TENIVAC lot number not reported. On an unknown date, patient developed a non-serious high fever (pyrexia) following the administration of ADULT TENIVAC. (Other relevant tests included no lab data.) Final diagnosis was high fever. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for high fever.
Received 0.3 ml  of Pfizer -grey top for 12 yr. and older.
When baby was awakened at 8am, she was covered head to toe with a raised pin point type of red rash. Fever 100.3. Mother took her to emergency room at 6pm on 9/25/13 for the rash.
On 5/24/01 the pt was fussy in the PM with a fever of 104. The following AM seen in the office.
Terrible pain under the arm at the fatty of the brest; Chills; Swollen; A little bit hurt; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swollen), PAIN IN EXTREMITY (A little bit hurt), AXILLARY PAIN (Terrible pain under the arm at the fatty of the brest) and CHILLS (Chills) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 1138) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No adverse event reported).    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced PERIPHERAL SWELLING (Swollen) and PAIN IN EXTREMITY (A little bit hurt). On 15-Jan-2021, the patient experienced AXILLARY PAIN (Terrible pain under the arm at the fatty of the brest) and CHILLS (Chills). At the time of the report, PERIPHERAL SWELLING (Swollen), PAIN IN EXTREMITY (A little bit hurt), AXILLARY PAIN (Terrible pain under the arm at the fatty of the brest) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
No Adverse Event- Patient was given Intial Pfizer dose instead of the Bivalent Booster
Patient notified me  6/3/21.... Patient states that he developed a blood clot behind his right eye. and the result of this clot caused him to lose site in his right eye.
first dose given 7/19/21  and on 7/28/21 unable to read eye chart for eye exam that she had been able to do so last year. I was not made aware that vaccine had been given at that time. informed of 2nd injection after the fact - notice mother unable to walk without help, not eating and  seen weak and loosing weight. taken to PCP  on 8/24/21 where she vomited in office- referred to ER where she was admitted to hospital.
Pt got flu shot on 10/3/01 at 11:00 and then developed a fever of 105F (R) at 03:00. Treated with Motrin and Tylenol and the fever went down to 101F by 08:00. The pt had emesis X 1 at 08:00.  A follow up report received 10/10/2001 adds: Child has recovered as of 10/08/01.
Malaise days 3-5; nausea days 4-5, painful injection site days 1-5,  muscle aches days 2-5, headaches days 2-5.
swelling upon administration; This is a spontaneous report from a contactable consumer (patient).   A 63-year-old adult male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration at the "top of the arm" on unknown date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and the patient's concomitant medications were not reported.  The patient experienced minimal to no pain (only some swelling upon administration) on an unspecified date with outcome of unknown.    No follow-up attempts are needed; information about lot/batch number cannot be obtained.
extreme varicose vein after 5 days after the first dosage. I felt a lot of stabbing like pain in my legs, both legs, but left leg was more acute than the right leg. By day 10 i was no longer to do my daily routine without taking breaks to rest my legs. Please note I went through 3 pregnancy(3deliveries) and with the hormones going up and down, i have not experience the leg pain i have with this vaccine. Even to this i still have pain into my left leg, ALL DAY NONE STOP.
I had not been feeling well on the Saturday morning. By the evening I had gotten much worse and ended up taking a COVID-19 home test and it was positive. I was having a headache, fever, my body was aching, congestion, a cough, and I was so tired. I ended up reaching out to my doctor's office on Sunday and did a telehealth appointment with them. At this point I had taken two COVID-19 Home Tests and they were both positive. Due to my symptoms and the fever, they gave a prescription for Molnupiravir because I had not gone in and done blood work to get Paxlovid. I was really sick for about ten days and was very sick through this time and just miserable. The fever did come down, but I was so tired and unable to think clearly.
Elevated Temperature, pt did not monitor. By Wed. Morning 10/14/09 left deltoid red swollen and feverish @ injection site.  By evening of 10/14/09, blotchy itchy rash on  bilateral arms, neck and body.  On 10/16/09  Rash still evident but patient reports getting less red with less itching.
intense abdominal pain 2 days after followed by intense nausea ( no vomitting) , dehydration, inability to urinate  Went to ER at approx. 1:30 am on 4/15 after hours of abdominal pain Immediately diagnosed with high liver enzymes, CT scan of belly completely normal, EKG normal, ultrasound normal  AST 1765, ALT 1569, checked 6 hours later AST 4755, ALT 4359 was accepted by hospital waiting on bed - no hospital would take me except large big hospital as I needed liver team  started on NAC per poison control recommendation every 4 hours for approx 2 days and liver specialist ( acute injury consistent with medical toxicity )  did not take any new meds and liver enzymes on checkup  6 weeks prior were completely normal  all liver tests came back negative (hepatitis, CPK, viruses etc. )  started on IV antibiotics immediately and fluids  Hospital added potassium to treatment  labs checked every 6 hours were continuing to go down after NAC treatment   Discharged on Monday night 4/19 ALT 797, AST 104 with instructions to get labs checked several times this week  current labs  ALT 377, AST 34
Itchy, red, swollen area around injection site. Swollen area is roughly 2 x 2? around injection site.
BACK PAIN; NECK PAIN; BUTT HURTS WHILE SITTING ON THE RASH/BRUISE; INFLAMMATION IN BLOOD; NOT BEEN NORMAL; LEGS HURT; BRUISY ON LEFT BUTTOCK; RASH LOOKING LIKE BLUE/PURPLISH DOTS ON LEFT BUTTOCK WORSENED; CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient concerned a 20 year old. Initial information was processed along with the additional information received on 18-MAY-2021. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805025, expiry: UNKNOWN) dose was not reported, 1 total administered to left arm on 08-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 09-MAR-2021, next day after vaccination, the patient experienced bruisy rash on the left buttock. The rash looked like a little blue/purplish dots, it started coming back and worsened. If the patient does anything with impact it comes back. On 04-MAY-2021, laboratory data included: COVID-19 antibody test also called as Abbott Chemiouninesent Microparticles Immunoassay SARS COV-2 IgG test (NR: not provided) no antibodies. The patient experienced confirmed immunological vaccine failure. On an unspecified date, the patient experienced back pain, neck pain, butt hurts while sitting on it if she has rash/bruise, legs hurt, inflammation in blood and not been normal since she got it (unspecified). Laboratory data (dates unspecified) included: Blood test (NR: not provided) inflammation. The patient had been to the hospital and saw like 6 healthcare professionals and nobody knew how to help her/fix it. The action taken with covid-19 vaccine ad26.cov2.s was not applicable.  The patient had not recovered from bruise on left buttock, back pain, neck pain, legs hurt, butt hurts while sitting on the rash/bruise, rash looking like blue/purplish dots on left buttock worsened, and not been normal, and the outcome of confirmed immunological vaccine failure and inflammation in blood was not reported. This report was serious (Other Medically Important Condition). This case is associated with Product quality complaint number 90000179797.; Sender's Comments: V0: 20210530406--Confirmed immunological vaccine failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS
chest pain near the shoulder; arm pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm pain) and CHEST PAIN (chest pain near the shoulder) in a 21-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B212A) for COVID-19 immunisation.     The patient's past medical history included No adverse event.    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Mar-2021, the patient experienced PAIN IN EXTREMITY (arm pain). On 21-Mar-2021, the patient experienced CHEST PAIN (chest pain near the shoulder). At the time of the report, PAIN IN EXTREMITY (arm pain) and CHEST PAIN (chest pain near the shoulder) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.
Bell's Palsy; This is a spontaneous report from a contactable consumer (patient). A 57-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration at age of 57 years, administered in Arm Left, on 12Mar2021 14:00  (Lot Number: EN6206) as single dose for covid-19 immunisation. Medical history included High Blood Pressure. The patient was not pregnant at time of vaccination. Concomitant medications included labetalol; furosemide; spironolactone. The patient previously took naproxen. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced Bell's Palsy (medically significant) on 16Mar2021 21:00.  The adverse event result in "Emergency room/department or urgent care". The patient received treatment of steroids and antibiotics for event. The patient was not diagnosed with COVID-19 prior to vaccination and not been tested for COVID-19 since the vaccination. Event outcome was recovering.
an allergic reaction it was not a severe; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A patient of an unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, on 11Mar2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient had an allergic reaction it was not a severe but when the patient returned on 01Apr2021 to get the second vaccine, the patient was told that could not receive it as the patient had a reaction to the first vaccine. The patient explained to them that it was not severe, they said that did not matter and the patient need to take the second vaccine in a hospital setting so they would not give second vaccine. They referred this to doctor's office, the patient's doctor's office did agree, they said it probably good to administer it in hospital setting, however they referred the patient to the local health department. The patient contacted the health department they said we won't approve that you need to be in a hospital setting so now I am here back and forth. The patient asked that do I really need to a hospital to have the second vaccine done, I am running out of time right now. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
headache, sore throat, cough, fever, chills, body aches, sinus congestion, nasal congestion. starting 12/26/21