chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial report received on 20 October 2011 from a consumer via the company's web site. This case is not medically confirmed. A male patient (date of birth not provided) had received a dose of FLUZONE HIGH-DOSE (lot number not reported) on 19 October 2011 at 2pm and around 6pm that evening the patient experienced fatigue. He took a 20 minute nap, woke up with chills, numbness in the fingers and toes, and a slight ache. He was up until around 8pm and then went to bed. He awoke around 3am the next morning in a cold sweat and then all the symptoms subsided. He felt a little out of sorts on 20 October 2011, but not too bad. In the past he has only experienced arm soreness at the site with other shots and no ill effects. Recovery status was not reported for the out of sorts feeling. Follow-up information was received from a consumer, who was also the patient, on 16 March 2012. The patient received the injection on 19 November 2011 at about 2:00PM. The patient had no illness at the time of vaccination, no adverse events to prior vaccinations and received no other vaccinations within four weeks of FLUZONE. The patient's concomitant medications included warfarin, DIGOXIN and TOPROL. The patient's outcome was recovered. Documents held by sender: None.
Golf ball size lump at injection site. Warm to touch. Small painful lump in pt arm pike cool compresses.
Patient got up from chair, walked away, and proceeded to loose his balance and fall. He did bump the back of his head, but he did not completely pass out. He was moved to a chair. He was very clammy + sweaty. Pulse was weak. BP was very low. Paramedics came. He was becoming more coherent, but was taken to ER due to low BP 70/45.
pt recv vax; 1-2 hr later fussy, painful, began high pitched crying, screaming;apap given; taken to er;crying lasted 3 hr; apap & codeine;sz resolved in 1-2 days;
Death within 30 days of vaccination, vaccinated on 3/5/2021 pronounced dead on 3/6/2021. Unknown if any side effects from vaccine.  No ER visit found at local hospital.
CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient concerned a 70 year old male. The patient's height, and weight were not reported. The patient's past medical history included: hypothyroidism, and concurrent conditions included: hypertension, non-alcohol user, non-smoker (quit smoking in 1991), unspecified auto immune disease, celiac disease, immunocompromised, penicillin allergy (cardiac arrest), sulfa allergy (rash), and rheumatoid arthritis, and other pre-existing medical conditions included: The patient had no history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported and batch number: 1808980 expiry: 18-SEP-2021) dose was not reported, one total, administered on 07-APR-2021 to right arm for prophylactic vaccination. No concomitant medications were reported.  On 24-AUG-2021, the patient experienced confirmed immunological vaccine failure. The patient had done antibody test and stated that did not known specific of the test that was done and whether the antibody was against the spike protein. Laboratory data included: Blood test (NR: not provided) zero antibodies. The patient further stated that had done COVID-19 virus test (NR: not provided) couple of months after vaccination result was Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210854815-COVID-19 VACCINE AD26.COV2.S-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
The morning of 1/27, the day after the shot, I awoke with floaters in both eyes and a flasher in the right eye.  On the following morning 1/28 I awoke with a headache and fever(100 - 101) that lasted through 1/29 and 1/30.
This case was reported by a physician and described the occurrence of multiple sclerosis symptoms in a 58-year-old male subject who was vaccinated with LYMERIX (GlaxoSmithKline). On an unspecified date the subject received LYMERIX (details unknown) as part of a clinical trial. The subject was enrolled in the trial 10 to 15 years prior to the time of reporting. GSK could not track the information to an individual clinical trial subject. Years after vaccination with LYMERIX, the subject experienced multiple sclerosis symptoms, unqualified visual loss in one eye, cataract, demyelination, neuroborreliosis and seropositive for lyme disease. The subject had reported abrupt loss of vision in one eye, but the physician reported that approximately 6 months ago the subject experienced vision problems and was operated for cataract. His vision did not improve and he subsequently lost the vision in one eye. MRI scan revealed demyelination. The subject's neurologist considered that the findings were not consistent with multiple sclerosis, but could be due to tertiary neuroborreliosis. The neurologist had not made a clear diagnosis. Lyme serology was positive, but the physician reported that it may have been due to the vaccine as the vaccine band was seen. This case was assessed as medically serious by GSK. At the time of reporting the outcome of the events was unspecified.
Unable to lift arm; Low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MOVEMENT IMPAIRMENT (Unable to lift arm) and PYREXIA (Low grade fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product PALBOCICLIB (IBRANCE) for an unknown indication.    No Medical History information was reported.   On 05-Jun-2021, the patient started PALBOCICLIB (IBRANCE) (unknown route) 125 milligram. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (Unable to lift arm) and PYREXIA (Low grade fever). At the time of the report, VACCINATION SITE MOVEMENT IMPAIRMENT (Unable to lift arm) and PYREXIA (Low grade fever) outcome was unknown.            No concomitant medications were reported.  Treatment information was not provided.
Approx 16 hrs after the 2nd dose: fatigue, muscle pain, stabbing pain, nausea, headache, dizziness
doctor told her not to receive the second shot since she had an allergic reaction; This spontaneous case was reported by a patient and describes the occurrence of HYPERSENSITIVITY (doctor told her not to receive the second shot since she had an allergic reaction) 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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPERSENSITIVITY (doctor told her not to receive the second shot since she had an allergic reaction). At the time of the report, HYPERSENSITIVITY (doctor told her not to receive the second shot since she had an allergic reaction) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was withdrawn on an unknown date.       No concomitant medications were reported. No treatment medications were reported.
the patient was dizzy and weak and spent 3 weeks in bed/ continued feeling dizzy and weak for 3 months; the patient was dizzy and weak and spent 3 weeks in bed/ continued feeling dizzy and weak for 3 months; the patient received 1 or 2 doses of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) 3 years ago; This spontaneous report has been received from a nurse prescriber concerning a 15 years old female patient. Information about medical history and concomitant therapies was unknown by the reporter. The patient had no drug reaction/allergies.  On an unknown date in June 2016 (reported as 3 years ago), the patient was vaccinated with 1 or 2 doses of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection (strength, dose, frequency, route, lot number and expiration date were not reported) as pediatric vaccines for prophylaxis (Inappropriate schedule of product administration).         On an unknown date, the patient was dizzy and weak and spent 3 weeks in bed. Then the patient "returned to school but continued feeling dizzy and weak for 3 months". The reporter did not know if the patient received any treatment. On 07-JUN-2019, the reporter saw the patient for the first time. The outcome of the events was reported as recovered (date unknown).  The causality between the events and HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) was not provided.
1/11/13 1848 pt received 4 shots developed welts like rash all over body. Goes all the way around her neck like she is being strangled, received vaccine at 1556 that day. Pt advised when called office at 1848 to go to ER immediately. Pt treated in ER on 1/11/13.
Pt recvd flu vax @ 10AM & by noon began to feel weak; By dinner time throat felt like "had had a shot of novicaine; also c/o feeling shaky but says this occurs quite easily; Did not notify MD or ER; voice is still not right, lips numb;
Asthma event sudden onset Thursday 4/15/21 @ 9 PM.  Felt bronchial tubes begin to constrict with wheeze and in ability to take a full breath.  Began using Ventolin as prescribed.  Continued using through Friday 4/16/21 until 7-8 PM began to feel some relief.  Awoke Saturday 4/17/21 - 9 AM able to take full deep breath.  D/C?d ventolin.    This was not a normal experience for me when my asthma kicks in ... it?s gradual, lasts several days and almost always drops into my chest and requires a breathing treatment @ my PCP office/clinic.
The first day after the vax was fine, but towards the end of the day I felt strange.  Half way through the second day, my pancreatitis came back with a vengeance for about a month, along with whole body inflammation for about a week, resufacing of neuralgias and other pain also.   The first week was the worst.  The whole body inflammation went away after a week.  But the pancreatitis flare up was worse than experienced before, and the amount of pain increased since the injection of the pancreas has increased by about 10 to 15 %, and has not returned to pre-vaccination levels.  I am taking more tramadol than ever now.     I WILL NEVER GET A COVID VACCINE AGAIN.
1510: Reported face flushing, rash to bilateral hands, reports history of multiple allergies and "I feel removed and tingling all over." Placed in gurney under RN observation.  1515: BP 129/84, HR 71, Temp 36.8C oral, RR 18, SP02 98% on Room Air 1528: BP 139/81, HR 70, SP02 98% on Room Air, Given Benadryl 50mg PO under direction of Pharmacist, tolerated well, continued to monitor.  1540: BP 131/84, HR 75, SP02 97% on Room Air, Temp 36.7C oral 1548: BP 138/88, HR 84, RR 18, Temp 36.7C oral, SP02 97% on Room Air, ambulatory, speaking in full sentences, appears stable, Disposition: sent home with spouse after extended observation by RN, advised to notify PCP.
I administered the AFLURIA vaccine on 10-23-15. Patient called 11-18-15 saying her shoulder joint had been hurting her since she got the injection. She said her arm had been hard to raise and she had difficulties dressing. She had history of bursitis. She had flu shots in past but it had never affected her in this way. Recommended warm compress and TYLENOL or ibuprofen.
w/in 3hr eyes were rotating back & forth;sz/inflammation of spine-brain;created allergies; MD dx w/cerebral palsy, encephalopathy & developmentally delayed;
rash is very itchy; warm to touch its going all way down to elbow; fever; little chills; rash; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (rash is very itchy), FEELING HOT (warm to touch its going all way down to elbow), RASH (rash), PYREXIA (fever) and CHILLS (little chills) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced RASH (rash). On 08-Mar-2021, the patient experienced PYREXIA (fever) and CHILLS (little chills). On 15-Mar-2021, the patient experienced RASH PRURITIC (rash is very itchy) and FEELING HOT (warm to touch its going all way down to elbow). At the time of the report, RASH PRURITIC (rash is very itchy) and RASH (rash) had not resolved and FEELING HOT (warm to touch its going all way down to elbow), PYREXIA (fever) and CHILLS (little chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported by investigator No treatment medications provided by the reporter.   No treatment medications were reported.
Information has been received from a registered nurse concerning a 19 year old female with no previous medical history or drug allergies reported who on 17-APR-2008 was vaccinated with the first dose of GARDASIL (Lot # 659653/1448U), 0.5 mL I.M. and on 17-JUN-2008 was vaccinated with the second dose of GARDASIL (Lot # 659962/1740U). Concomitant therapy included oral contraceptives (unspecified). After administration of the second dose, the patient developed a pain in her neck, chest and back area and was diagnosed with a pulmonary embolism. The patient was being treated with COUMADIN. On an unspecified date, the patient recovered. The patient sought medical attention at the office. Upon internal review, pulmonary embolism was determined to be an other important medical event. Additional information has been requested.  4/14/09 Received hospital medical records of 7/25-7/29/2008. FINAL DX: acute pulmonary embolism Records reveal patient experienced right side neck/chest pain since 7/18 which progressed to SOB & bloody sputum.  Seen by PCP & CXR found to be abnormal.  Sent to ER & found to have RLL PE assoc w/pleural effusion & atelectasis.  Tx w/anticoagulants.  Genetic testing done for possible predisposition for clotting was neg.  Cardio consult done for abnormal echo.  Improved & d/c to home on continued anticoagulant therapy w/PCP & cardio f/u w/additional clotting w/u to be performed as outpatient.    4/29/09 Received vaccine & GYN medical records of 4/17-10/23/2008. FINAL DX: pulmonary emboli Records reveal patient experienced good general health when seen for initial evaluation on 4/17 for HPV#1 & started OCP at that time as well.  RTC 6/17/08 for HPV#2.  D/C OCP 8/08 due to PE.  Developed RLQ pain 10/08.  6/29/09 Received Factor V Leiden & gene mutation test results.
Had a sore throat & chills second night after receiving vaccine. Today Sunday 1-24-20 woke up with "head cold" like symptoms runny nose, constant sneezing, itchy eyes & sore throat
Menstrual cycle got really messed. Some months I would 2-3 times, and other months none. It also got really heavy and more painful. The problem is still ongoing.
Pt stated she had rash from head to toe with tiny bumps, a yeast infection on skin, and an ulcer.  Pt stated the symptoms started a day after the vaccine. The rash and yeast infection has continued for 3 weeks
Patient complained a 36 hours after the first dose of Moderna she felt stiff on left arm and leg, her fingers and toes clinched involuntary, her Left fingers were numb as well.
Patient given HPV immunization. Patient was sitting approximately 3-4 minutes after patient experienced episode with LOC, stiffened, eyes rolled, twitching complained of headache after which cleared after lying down app 5 min.
Pt called; rt eyelid puffy -> kept getting bigger. Eyelash & lid discomfort. Pt did not call back when 3 attempts were made.
Injection site pain; Swollen injection site; chills; Slight fever; Muscle ache all over the body; This is a spontaneous report received from a non-contactable pharmacist, the patient. A 33-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: 3248) via the unspecified route of administration on 23Mar2021 at 10:45 hours (at the age of 33-years-old) as a single dose, for COVID-19 immunisation. Medical history included seasonal allergy from an unspecified date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications were not reported. On 23Mar2021 at 23:00, about 12 hours after the vaccination the patient experienced injection site pain, swollen injection site, chills, slight fever, and muscle ache all over the body. The symptoms lasted for about a day and resolved. The event did not result in a doctor or other healthcare professional office/clinic visits, and the emergency room/department or urgent care visits. The patient did not receive any treatment for the events. The clinical outcome of the events injection site pain, swollen injection site, chills, slight fever, and muscle ache all over the body was recovered on 24Mar2021.   No follow-up attempts are needed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: updated lead sentence to reflect "non-contactable pharmacist"; narrative verbatim updated as "Since the vaccination, the patient had not been tested for COVID-19".
48 hrs after immun. were given child was taken to Emergency Room.  L arm red/swollen/hot to touch and "very tight" from elbow to shoulder.  MD examined site and prescribed an antibiotic and gave Benadryl.  No systemic effect/activity normal.  By 5th day pt. was fine.
Patient fainted, called 911, no treatment given. According to family pat has history of fainting with vaccination.
PT REPORTED TIGHTENING OF THROAT. NURSE PRACTITIONER AT CLINIC MADE DETERMINATION THAT EPIPEN WAS NOT NEEDED, SINCE THAT WAS THE ONLY ADR. PATIENT REQUESTED TO BE SEEN AT CLINIC. PATIENT WAS ALLERGIC TO PHENOL.
3/19/21 I noticed some mild soreness and tenderness in my left arm where I received the Moderna vaccine. The next day 3/20/21 a raised red rash appeared on my upper arm at the injection site. It is about the size of my hand and is very tender. There is mild itching. The skin also feels warmer than elsewhere on my arm and body.
SHE WAS IRATE! MY DAUGHTER IS VERY SHY, RESERVED, QUIET! SHE IS AN HONOR STUDENT! NOT IN HER CHARACTER AT ALL!!!! SHE WAS NOT HERSELF!! SHE WAS PHYSICAL LAST NIGHT W ME AND MY BF! SHE WOULD NEVER EVER LIFT A FINGER TO ANYONE!!!!! SHE WAS JUST SO IRATE AND FROM WHAT I COULD SEE SHE WAS NOT HERSELF SHE HAD A LOOK IN HER EYE I HAVE NEVER SEEN!! I DO NOT BELIEVE SHE KNEW WHAT SHE WAS DOING!! I PERSONALLY THINK IT WAS TO MANY SHOTS FOR SOMEONE WITH HER HISTORY OF ASTHMA AND ALLERGIES!!! SHE WAS NOT HERSELF!!!!!!!!! IT WAS MORE THAN A MILD IRRITABILITY LIKE THE SIDE EFFECTS SAY!!!!!
3/16/2023 symptoms were fever, cough, runny nose, and fatigue. I stayed home and went to doctor 3/17, rapid COVID-19 test, positive, along with Flu and Strep, negative. Doctors didn't prescribe any medication. Fever went away after a day. Congestion lasted at least 3 weeks and the cough lingered until about 4/20. Fatigue lingers to time of reporting.
Patient started to felt dizzy and have hard time swallowing her water. Before this event, I counseled her on potential side effects and confirm her health status. When I came to assist her, she was not having any respiratory distress nor having any severe anaphylactic reaction so no Epipen was used. I applied ice pack on her and she started to feel better a few minutes later.
Information has been received from a physician and a healthcare professional concerning a 16 year old female who on approximately 15-JAN-2008 was vaccinated with a first dose of Gardasil (659439/1267U).  On approximately 15-JAN-2008 following vaccination the patient became pale and woozy, and had to lay down.  Unspecified medical attention was sought.  Outcome unknown.  There was no product quality complaint.  This is one of several reports received from the same source.  Additional information has been requested. Initial and follow-up informatin has been received from a physician and a healthcare professional concerning a 16 year old female who on 21-JAN-2008 was vaccinated with a first dose of HPV vaccine (659439/1267U). At 15:15, on 21-JAN-2008 following vaccination the patient became pale and woozy, and had to lay down. In follow-up it was reported that the patient became lightheaded and dizzy. The patient was plasced on the exam table. The vital sign were stable. Patient remained in room for 30 minutes. Unspecified medical attention was sought. The patient left the office feeling fine. There was no product quality complaint. Additional information is not expected.
I have been sick just with a flu; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot and expiry not reported), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Consumer stated, "I am just calling to see since my second dose was due today, but I was unable to get it because I was so sick and I have been sick just with a flu. I am just calling about the question for Covid-19 Vaccine from Pfizer." The outcome the event was unknown.  Information on the lot/batch number has been requested.
-fever -chills/shaking - joint pain  - pain in injection arm - full body pain  -headache  -fatigue
Patient experienced pain and swelling on left upper arm. Arm was swollen and tender. Patient complained of pain to touch. Patient took MOTRIN OTC and was advised to use an ice pack.
site warm to touch and consistent with cellulitis versus local injection reaction.  Swelling, red and fever
Itchy rash at vaccine site; Itchy rash at vaccine site; vomiting last night; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE RASH (Itchy rash at vaccine site), VOMITING (vomiting last night) and VACCINATION SITE PRURITUS (Itchy rash at vaccine site) 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 an unknown date, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter, second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Apr-2022, the patient experienced VOMITING (vomiting last night). On an unknown date, the patient experienced VACCINATION SITE RASH (Itchy rash at vaccine site) and VACCINATION SITE PRURITUS (Itchy rash at vaccine site). At the time of the report, VACCINATION SITE RASH (Itchy rash at vaccine site), VOMITING (vomiting last night) and VACCINATION SITE PRURITUS (Itchy rash at vaccine site) outcome was unknown.            No concomitant medication was reported. Patient reported she was going to leave to get cortisone cream.   This case was linked to MOD-2021-047879 (Patient Link).