chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I had "Covid arm". Two days after my first dose I got a large lump in my skin at the injection area. It was very hard, sore, and whitish. It was about two and a half inches in diameter and raised about a quarter inch. The surface was uneven. Several hours later the lump was gone. Then I had a red, very itchy rash that spread from the injection site to the rest of my upper arm, and then to other areas. The reaction continued for about three days. The rash was so bad that I had to take Benedryl by mouth for a few days to  treat the symptoms.
Temperature 103, body aches, blinding headache, arm extremely sore, deep cough.  Total of 36 hours but now just dizziness and feeling exhausted.  Really thought about going to hospital and I have never been that sick in my life.
Pt admits 1 hour after vaccination, she started to have itching around the injection site. Later on that night she started to have blue/purple skin around injection site and spread. She write one day and on Saturday went to see doctor. She admits Dr. run tests and told her that her blood coumadin levels were high. Patient admits Dr. told her it will go away in a couple of days, and that everything is normal.
pt recvd vax & vomited 5 hrs after vax; became lethargic;  adm to hosp for observation; began sucking 3 hr after v; sl inc WBC;  HB 9.9; x-ray neg; seem to improve; vomited x 1 next am;
Pt developed some presyncopal symptoms, but did not pass out. She shortly afterwards developed right arm numbness and paralysis. She had intact deep tendon reflexes. Was sent home to observe, but they went to the ED that night due to her symptoms persisting and developing some arm pain. Was thought that she had a conversion disorder. Her symptoms gradally improved over the following week, having totally resolved a week later.
Initially-low grade fever, swollen glands, w/in month blisters swelling on feet/ diagnosed with Epidermolysis Bullsoa Aquisita in June 2008.
died, received the Pfizer vaccine; massive heart attack; she wasn't feeling well; This is a spontaneous report from a non-contactable consumer or other non hcp.   A 74-years-old female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: UNKNOWN), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient had vaccine on an unspecified date and within one day, the patient stated she wasn't feeling well. It was reported that she had massive heart attack. The reporter reported that the patient died on an unspecified date and do not know what happened. The patient died on an unspecified date for an unspecified reason. It was unknown weather autopsy was performed or not. The outcome of she wasn't feeling well and massive heart attack was unknown.  Request Name: REQ-347122 Product: PFIZER-BIONTECH COVID-19 VACCINE Question: Has anyone reported Heart attack or stroke? Response: Spoke from attached document: In the all-enrolled population of (total N=43,448), the proportions of participants who reported at least 1 SAE during the time period from Dose 1 to the data cutoff date (November 14, 2020) were 0.6% in the BNT162b2 vaccine group and 0.5% in the placebo group. The most common SAEs in the vaccine group which were numerically higher than in the placebo group were acute myocardial infarction (0.02%), and cerebrovascular accident (0.02%), and in the placebo arm numerically higher than in the vaccine arm were pneumonia (0.03%), atrial fibrillation (0.02%), and syncope (0.02%). Occurrence of SAEs involving system organ classes and specific preferred terms were otherwise balanced between treatment groups, including no imbalance overall in cardiovascular serious adverse events. Offered to email for review, caller declined.    No follow-up attempts are possible, No further information is expected.
I still had a red mark on the arm; This is a spontaneous report from a non-contactable consumer(patient).     A patient of unspecified age and gender received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot Number: Unknown) as single dose for COVID-19 immunization. Medical history included neoplasm malignant from an unknown date.  The patient had a red mark on the arm on an unspecified date. The patient have a lot of Problem in hearing you there's a lot of fan in the background. Chemo medications and she had the first vaccine (Further clarification was unknown hence captured as unspecified vaccine) shot on the 14th and have another on the 6th but patient have a red mark on the arm of the size of quarter and the oncologist want me to have the vaccine. So the patient had the first shot but patient concerned since the patient was a cancer patient that still had a red mark on the arm. The patient do not know if should have the second shot or not. The outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
ERROR IN PATIENT HISTORY RESULTED IN ADMINISTRATION OF BIVALENT BOOSTER THAT WAS RECENTLY AUTHORIZED FOR AN ADDITIONAL DOSE IN COMPROMISED OF 65+ POPULATIONS AT 15 WEEKS PAST THE LAST ADMINISTRATION INSTEAD OF 4+ MONTHS
I have never had blood pressure issues before - developed hypertension about ~ 1-2 Weeks after taking the vaccine. Sometimes blood pressure is 150*100 which is extremely high and classified as hypertension. Prior to that, never had blood pressure higher than 130*85.  The episodes of hypertension never stopped. Developed high fever (102.6 F) on the night of the vaccination that lasted for 2-3 Days. Developed aches throughout the body that seem like nerve pain.
Patient got her second dose of the Pfizer vaccine on 4/20 and started to feel a headache come on and believed it was due to a migraine. On 5/1 she went to her local ED and was given migraine treatment. She continued to have worse headaches and developed subsequent L homonomous hemianopsia, L sided weakness, and L sided neglect. She presented to the ED on 5/5 and was found to have cerebral venous sinus thrombosis confirmed by head CT. Other risk factors include active COVID-19 infection (unknown at time of vaccine administration) and OCP usage.
Administration error - 11 yo was inadvertently administered a 3rd dose of Pfizer Pediatric COVID-19 vaccine.  Second dose was on December 3, 2021.  Mother was advised as to the error; she thought all people could get a booster regardless of age or timing.  Mother was advised to monitor the child for any adverse reaction and to call the local dept. of health if anything abnormal occurred.
postherpetic neuralgia; vision issues; multiple outbreaks of herpes zoster; Information has been received from a lawyer regarding a case in litigation and refers to a female patient (pt) who at the time of report was approximately 67 years old. No information was provided regarding the pt's medical history, concurrent conditions, or concomitant medications. On or about 04-OCT-2016, the pt was vaccinated at her local pharmacy with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot #, and expiration date were not reported) for the long-term prevention of shingles and zoster-related conditions. Subsequently, on unknown dates, the pt was treated by providers for the following injuries resulting from zoster vaccine live (ZOSTAVAX) use: multiple outbreaks of herpes zoster, postherpetic neuralgia and vision issues. The outcome of the events was not reported.  The lawyer considered the events of multiple outbreaks of herpes zoster, postherpetic neuralgia and vision issues to be related to zoster vaccine live (ZOSTAVAX).
Patient had pain in her arm. It radiated up to her neck and made it painful to put on a sweater, drive her car, or lie down. Sometimes she got headaches. Tylenol didn't seem to help.
Patient was accidentally given 1 extra dose of MMR after staff member transcribed the vaccine record. MMR dose #1 was annotated on the front of the shot record under the MMR sub-section. MMR dose #2  was annotated on the back of shot record under the other sub-section.
Immediately tasted a metallic taste and numbness in my cheeks. When I got home I had a rapid heart rate and slight shortness of breath. That night I ran a fever of 102 and had horrible chills and nausea. The next day these were gone but I had a horrible headache that even Tylenol wouldn?t get rid of. The second day these symptoms had stopped.
This spontaneous report was received from a healthcare worker via a physician referring to a patient of unknown age and gender (demographics not reported). It was reported that on an unknown date in 2009 the patient was vaccinated with PNEUMOVAX 23 (lot# not reported). No other concomitant therapies were reported. On an unknown date the reporter stated that patient was in need of surgery (medically significant) for unspecified medical condition. The healthcare worker stated that the medical condition was not pre-existing when PNEUMOVAX 23 was administered. There was no PQC reported. The reporter enquired if PNEUMOVAX 23 was company's product and if it was available in the year 2009. The outcome the events was unknown. The causality of the events was unspecified. Upon internal review, the event of 'in need of surgery' was considered to be medically significant. Additional information has been requested.
I broke out with a rash the day after my second shot and it progressively got worse. I went to urgent care after a week and was put on an antibiotic and prednisone. The rash slowly went away but still I am itchy constantly and is now red blotchy is back.
Symptoms the night of seemed normal. Fever, headache, body sores, etc. Those lasted about two-three days. But now, 6 weeks later, I am still experiencing headaches on and off. I have never experienced headaches like this prior to the COVID vaccine. I also still feel weakness and dullness in the muscle injected.
Mom reports had a giant lump larger than the size of a softball and very bright color of red the night of the injection. Child had no apparent fever.  Mom did not notify physcian of swelling and redness, after injection.  Child came in for 2nd Varivax injection and was questioning nurse whether it was normal to have such a large lump after shot.  Nurse held 2nd Varivax and reported incident to Nurse Practitioner.  Redness and swelling lasted for four days.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown demographics. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 05-JAN-2011, the patient was inoculated with ZOSTAVAX by a healthcare provider as recommended for permanent prevention and protection against shingles and zoster-related conditions (dose, route, and lot # not provided). On an unknown date, the patient was diagnosed with shingles and/or zoster related injuries after and despite being inoculated with ZOSTAVAX vaccine and suffered serious mental and physical pain and suffering and required extensive medical care and treatment. On or about 04-APR-2013, the patient was treated by a healthcare provider for shingles. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other medical related expenses which includes but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications and supplies. The outcome of the events was unknown. Causality assessment was related.
atypical measles w/confluent, red maculopapular rash, blanching on face, neck, chest, & back;rash appeared 10 days p/vax given;when given pt also dx w/BOM & started on ATB;
Injection site pain; Injection site swelling; Injection site redness; Arm pain; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 27 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 17Sep2021 14:30 (Lot number: FC3182) at the age of 27 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Covid" (unspecified if ongoing), notes: if covid prior vaccination Yes. Concomitant medication(s) included: EMOQUETTE. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 18Sep2021, outcome "not recovered", described as "Injection site pain"; VACCINATION SITE SWELLING (non-serious) with onset 18Sep2021, outcome "not recovered", described as "Injection site swelling"; VACCINATION SITE ERYTHEMA (non-serious) with onset 18Sep2021, outcome "not recovered", described as "Injection site redness"; PAIN IN EXTREMITY (non-serious) with onset 18Sep2021, outcome "not recovered", described as "Arm pain". Therapeutic measures were not taken as a result of vaccination site pain, vaccination site swelling, vaccination site erythema, pain in extremity. Additional information: The patient was administered the most recent COVID-19 vaccine was Pharmacy or Drug Store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient has not been tested for COVID-19. Device Date : 19Sep2021. The patient do not have Known allergies and Other medical history. No follow-up attempts are possible. No further information is expected.
Terrible body aches all over. Intense pain in hip joints,lower back neck, knees Any movements caused pain. Pain came on about 12 to 15 days after the Moderna booster shot, my 3rd in the series. Dr. put me on meloxicam.  The medication has really helped, but if I stop taking it symptoms come back,and movement of my body is very painful again.
Throat swelling with no problems breathing. Immediate reaction after vaccine after leaving pharmacy. Used albuterol inhaler to help with symptoms. Said symptoms on and off for 2 weeks.
This spontaneous report was received from a female nurse via company representative regarding herself. On an unknown date, the nurse had accidentally been contaminated with a drop of ZOSTAVAX, and she cleaned the surface with an alcohol wipe. On an unknown date, a few days later, she developed shingles. The severity of infection, treatment provided, outcome of the shingles and causality assessment were not reported. No product quality complaint (PQC) was involved. Additional information has been requested.
This spontaneous report as received from a pharmacist refers to a patient of unknown age. On 09-MAY-2013 the patient was vaccinated with a dose of expired ZOSTAVAX (lot # 0168AE, expiration date 06-MAR-2013, 0.65 ml, subcutaneously, indication not reported). No adverse effects reported. Additional information has been requested.
After client received vaccine client states she has tingling in her fingers, pain in both sides of lower neck, dry mouth.  Vitals obtained by EMS O2 sat 99%, BP 168/87, Pulse 100. Client states she is feeling better.  Client discharged home.   Client advised to call if symptoms return.
received a dose of BEXSERO that expired; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 16-year-old female patient who received Men B NVS (Bexsero) (batch number unknown, expiry date 31st January 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 16th February 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 16th February 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The case is reported by the Practice manager. The reporter stated that, a patient received a dose of Bexsero that was expired, which led to expired vaccine used. The mother of the patient was notified. The lot number was not available at this time. The Vaccine administration facility was the same as Primary reporter. The reporter consented to follow up.
FEELING NUMB ON RIGHT SIDE INCLUDING ARM AND LEG; WEAKNESS ON RIGHT SIDE INCLUDING ARM AND LEG; NAUSEA; COLD SWEATS; FEVER; CHILLS; This spontaneous report received from a patient concerned a 44 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A expiry: UNKNOWN) dose was not reported, administered on 02-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-JUN-2021, the subject experienced cold sweats. On 02-JUN-2021, the subject experienced chills. On 02-JUN-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 103 F. On 03-JUN-2021, the subject experienced nausea. On 04-JUN-2021, the subject experienced feeling numb on right side including arm and leg. On 04-JUN-2021, the subject experienced weakness on right side including arm and leg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from cold sweats, chills, and fever on 04-JUN-2021, had not recovered from nausea, and weakness on right side including arm and leg, and the outcome of feeling numb on right side including arm and leg was not reported. This report was non-serious.
Patient started having difficulty breathing  2 days after receiving the second dose of Pfizer vaccine.  Patient states she has had a 2-3 week history of  tongue swelling, inner cheek swelling, lip swelling with itching.  Patient has severe mouth pain and the inner lips are peeling.
Very bad throat, could not eat or drink, talking out of head, night and day, Started going into seizures in the emergency room of Medical center.  had ultrsound of leg for swelling and redness earlier.  Seizures for a month. Transferred to Care Center.  Had not treatment or medicaltions thereafter due to lockdown which was in process when the patient died.
racing heart/pounding heart; fatigue; feel as bad as I did; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 09Apr2021 12:45 (Batch/Lot number: unknown) at the age of 65 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Bartter Syndrome" (unspecified if ongoing); "previous Broken Synfrome" (unspecified if ongoing); "GERD" (unspecified if ongoing); "Known allergies: Yes" (unspecified if ongoing). Concomitant medication(s) included: SPIRONOLACTONE; TOPROL XL; SLOW MAG [MAGNESIUM CHLORIDE]. Vaccination history included: Bnt162b2 (Product: COVID 19,, brand: Pfizer,, lot unknown: True,, lot unknown reason: Not available/provided to reporter at the time of report completion,, administration date: 19Mar2021,, administration time: 12:00 PM,, dose number: 1,, vaccine location: Left arm), administration date: 19Mar2021, when the patient was 65 years old, for covid-19 immunization, reaction(s): "Racing heart", "severe fatigue". The following information was reported: PALPITATIONS (non-serious) with onset 09Apr2021, outcome "not recovered", described as "racing heart/pounding heart"; FATIGUE (non-serious) with onset 09Apr2021, outcome "not recovered", described as "fatigue"; FEELING ABNORMAL (non-serious) with onset 09Apr2021, outcome "not recovered", described as "feel as bad as I did". The events "racing heart/pounding heart", "fatigue" and "feel as bad as i did" were evaluated at the physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section, which included blood test, ECG and urine analysis, with results: unknown, on an unspecified date. Therapeutic measures were taken as a result of palpitations, fatigue, feeling abnormal.  Additional Information: Second dose caused racing heart and much, much more severe pounding heart and overwhelming fatigue with 2 emergency room visits. Patient was 19 days out from second dose and still feeling deep fatigue and not able to resume normal activities. patient feel as bad as his did within the first week of reactions. No other vaccine was administered in four week by the patient, patient had known allergies, it is unknown If Covid tested post vaccination to the patient.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Hive-type swelling, itching around injection area 8 days after receiving the vaccine.  Symptoms started on 1/30/20.   On 1/31/20 light-headedness and stomach upset symptoms, along with muscle aches across the neck, shoulders, and back, also headache.
she has a purple bruise and in the middle is a hard ball/ Has like a bruise, purple stain on her arm; she has a purple bruise and in the middle is a hard ball/ Has like a bruise, purple stain on her arm; She has a purple bruise and in the middle is a hard ball; All around the arm there is swelling on the arm; This is a spontaneous report from a contactable consumer. This female consumer (patient) reported for herself that: A female patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm on an unspecified date in 2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, on an unspecified date in 2021 as single dose for covid-19 immunisation and experienced the adverse events Had a bruise for 7 days and it hurt a lot for several days, swelling on the arm and the first time it was only purple and. Patient reported that she stated that she had no side effects from the second vaccine. She stated that she is now after months after getting the vaccine she has a purple bruise and in the middle is a like a little very hard ball on injection arm and swelling on the injection arm on an unspecified date in 2021. She stated that it occurred all of the sudden and she is really scared because the second dose was a long time ago. The case assessed as non-serious by the reporter. The outcome of the events was reported as unknown.   Follow-up attempts are completed. No further information is expected
Per MCIR, patient received two doses of Moderna COVID-19 vaccines on 2/111/2021 and 3/11/2021 and was subsequently hospitalized at our institution and diagnosed with COVID-19
Pt has injection site reaction about 6 in below injection site. red triangle area by elbow
A male consumer reported that he received an injection of Flu Shield (influenza virus vaccine, trivalent, types A & B) (1996-1997 formula) (manufacturer unknown) in November 1996.  48 hours post-immunization, he developed a rash on "numerous parts of his body".  The patient's physician prescribed a three week tapering dose of prednisone.  The patient indicated that he developes the "rash five times a year and is treated with prednisone."  No further information was availabe at the date of this report.