chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I experienced Atrial fibrillation in January 2022. The doctors put me more on medication. The A-fib would not go away. It would come and go. A cardioversion was done on March 2023. I have to go back in again and do another cardioversion on 4/21/2023.
The following events occurred after receiving the second booster of Pfizer on 7/19/2022. I was very sleepy on the first day.  On the morning of the second day, my head felt very heavy (congested); nagging headache; injection site pain for a couple of days (eventually went away); nausea 7/19 - 22/2022; fever beginning 7/24/2022 - 100.2, 99.9, 101.7; chills during the fever; my eyes also hurt to move during the fever period;
Pain in arm of injection that lingers on 2 months after injection.  Patient states pain is getting better but it still evident on 6-21-19
Nauseated; Affecting my balance; Legs crampy; Sore arm; Hard arm; Swelled arm; Red arm; I Sleep for a couple of more hours and that was unusual; Sick of my stomach; Arm started itching; Low grade fever; Didn't feel really good; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Arm started itching), PYREXIA (Low grade fever), MALAISE (Didn't feel really good), NAUSEA (Nauseated) and BALANCE DISORDER (Affecting my balance) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure and High cholesterol. Concomitant products included ROSUVASTATIN CALCIUM (CRESTOR OD) for High cholesterol, CLOPIDOGREL BISULFATE (PLAVIX) for an unknown indication.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jan-2021, the patient experienced PRURITUS (Arm started itching), PYREXIA (Low grade fever) and MALAISE (Didn't feel really good). On 19-Jan-2021, the patient experienced NAUSEA (Nauseated), BALANCE DISORDER (Affecting my balance), MUSCLE SPASMS (Legs crampy), PAIN IN EXTREMITY (Sore arm), INDURATION (Hard arm), PERIPHERAL SWELLING (Swelled arm), ERYTHEMA (Red arm), HYPERSOMNIA (I Sleep for a couple of more hours and that was unusual) and ABDOMINAL DISCOMFORT (Sick of my stomach). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PRURITUS (Arm started itching), PYREXIA (Low grade fever), MALAISE (Didn't feel really good), NAUSEA (Nauseated), BALANCE DISORDER (Affecting my balance), MUSCLE SPASMS (Legs crampy), PAIN IN EXTREMITY (Sore arm), INDURATION (Hard arm), PERIPHERAL SWELLING (Swelled arm), ERYTHEMA (Red arm), HYPERSOMNIA (I Sleep for a couple of more hours and that was unusual) and ABDOMINAL DISCOMFORT (Sick of my stomach) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details :Stomach sick medicine.  Concomitant medications also included blood pressure medication and blood thinner medicine.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 28-OCT-2015 08:52, the patient was vaccinated with improperly stored RECOMBIVAX HB with lot number: L016427, expiry date: 13-APR-2017 (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. The high temperature and low temperature were 5.8 and 2.9 respectively. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
Fever of 102 -104F (36hr) Body aches, shakes, and chills (36hr) Headaches (began 06/28/2021) headaches encompass the whole head with pain at the base of the skull/neck
Greater than 50mm area of eryrthema, warm to touch.  Cold pack and tylenol.  Advised benadryl for itching.
Diarrhea 1 week after 2nd vaccine, worse first week of 8/21.  CT in ED at hospital showed pancolitis
I began to have tinnitus in my left ear. It sounds like a motorcycle and will not stop. I've had strange pulsing pain in joints and in my muscles through my body. I've had itchy skin. And I feel like I'm in a mental fog.
The patient received Moderna vaccine.  She stated after the shot that she wanted Pfizer.  She has had a history of Pfizer vaccines.  At the time there are no adverse effects of vaccine.
Engerix-B - Pediarix administered on same day; This case was reported by a nurse via call center representative and described the occurrence of overdose in a 6-month-old male patient who received HBV (Engerix B pediatric) (batch number 2H575, expiry date 12th September 2022) for prophylaxis.   Co-suspect products included DTPa-HBV-IPV (Pediarix) (batch number 5N259, expiry date 5th October 2023) for prophylaxis and dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 2nd February 2022, the patient received Engerix B pediatric, Pediarix and Pediarix Pre-Filled Syringe Device. On 2nd February 2022, unknown after receiving Engerix B pediatric, Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced overdose. On an unknown date, the outcome of the overdose 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 reported as follows: The reporter was a nurse. The patient received a dose of Engerix B and Pediarix on the same day, which led to overdose of hepatitis B vaccine. Consent to follow up was granted.
No adverse event; patient got both Moderna primary series/to get the booster for the toddlers with the pink cap, but she got 0.25 of the other Moderna vaccine with the blue cap; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (patient got both Moderna primary series/to get the booster for the toddlers with the pink cap, but she got 0.25 of the other Moderna vaccine with the blue cap) and NO ADVERSE EVENT (No adverse event) in a 3-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 011H22A) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 Vaccine (patient got both Moderna primary series). Past adverse reactions to the above products included No adverse event with Moderna COVID-19 Vaccine.    On 12-May-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On 12-May-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced WRONG PRODUCT ADMINISTERED (patient got both Moderna primary series/to get the booster for the toddlers with the pink cap, but she got 0.25 of the other Moderna vaccine with the blue cap). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (patient got both Moderna primary series/to get the booster for the toddlers with the pink cap, but she got 0.25 of the other Moderna vaccine with the blue cap) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (patient got both Moderna primary series/to get the booster for the toddlers with the pink cap, but she got 0.25 of the other Moderna vaccine with the blue cap).    Concomitant medication details not reported by the reporter. Patient did not received any other vaccines in the 4 weeks prior to COVID-19 vaccine. Treatment details was not reported by the reporter.
Developed a hot red streak with a hard lump underneath - the redness is 3 inches long by one inch wide.
On the evening of 12/3, over 24 hrs after my Moderna booster (my first series was Pfizer and I only had side effects like fatigue, chills, and a low fever for 3 days after my second dose), I noticed that my right ankle/lower leg was itchy but didn?t think much about it. The next morning (9am on 12/4) I noticed I had hives/a rash in patches on my face, arms, legs, butt and lightly on my chest. All of it was extremely itchy. I took a Benadryl and the rash/itchiness eased after 1 hour.  By 7pm, the rash/hives had returned, this time on my back, butt, and part of my legs. I didn?t take anything, but drank a lot of water and went to bed. I woke up this morning at 5am and the itchiness was again extreme- the hives/rash had returned to my legs, arms,  and a small area of my face. I took an Allegra-D 24 hr tablet at 7:20am and my skin cleared within 30 minutes. I have only had hives one other time in my life (after drinking one glass of a certain type of red wine) so this immune reaction is out of the ordinary for me.
throwing up; headache; This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (throwing up) and HEADACHE (headache) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetic.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced HEADACHE (headache). On 04-Mar-2021, the patient experienced VOMITING (throwing up). At the time of the report, VOMITING (throwing up) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
I received the Moderna COVID-19 Vaccine.  Immediate effect was being tired on the morning after the shot because I did not sleep well.  Then slight fever later in the day.  Same on day two.  Day two and three also had red rash all over my upper body.
Initial and follow up has been received from a health professional for the Pregnancy Registry for GARDASIL concerning a female 18 years old patient with epilepsy, carpal tunnel syndrome, drug hypersensitivity to phenobarbital and a smoker, with a history of no prior pregnancies who on 01-OCT-2007 was vaccinated with her third dose of GARDASIL IM and was subsequently determined to be pregnant. The patient received her first dose of GARDASIL IM on 30-JAN-2007 and her second dose of GARDASIL IM on 20-APR-2007. Concomitant therapy included TEGRETOL, vitamin D (unspecified), folic acid (unspecified) and calcium (unspecified). The patient's estimated LMP was 28-JUL-2007 with an estimated conception date of 07-SEP-2007. The patient's estimated due date is 02-JUN-2008. On 17-OCT-2007 and 18-JAN-2008 the patient had ultrasounds which were normal for screening and to establish a due date. The patient also had a serum alpha-fetoprotein test which was normal. The patient sought medical attention by contacting the office. Follow up information received from a physician reported that on 12-JUN-2008, the patient developed arrest of active labor and required a cesarean section. She delivered a healthy, normal, 7 pound 15 ounce boy with APGAR scores of 9 and 9. There were no congenital anomalies. It was reported that the patient smoked throughout her pregnancy. The patients outcome was not reported. Upon internal review it was determined that the arrest of active labour requiring a cesarean section was an other important medical event. No additional information is expected.
pt recv vax 14OCT98 & the next day exp inj site pain which radiated to the axilla & to the elbow;tx w/applications of ice;
About 30 hours after the vaccine the skin under both arms turned bright red.  This extended down the inside of both arms and down both sides of my body. There was NO itching, bumps or streaks and no burning or heat.  I only noticed it when I took a shower.  This lasted about 36 hours and then faded and has not returned at this point, 9 days after the injection.  At about this time, I had extreme tiredness and exhaustion.  This has continued for the entire 9 days.  Both arms and legs feel heavy.  Headache for most of the 9 days.
her glands were swollen; a little tired; malaise; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): LRN3505976.  A 37-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Multiple sclerosis" (unspecified if ongoing); "uses a cane" (unspecified if ongoing); "seasonal allergies" (unspecified if ongoing); "gluten allergy" (unspecified if ongoing); "allergies to antibiotics" (unspecified if ongoing), notes: allergies to antibiotics. The patient's concomitant medications were not reported. The following information was reported: LYMPHADENOPATHY (non-serious), outcome "unknown", described as "her glands were swollen"; FATIGUE (non-serious), outcome "unknown", described as "a little tired"; MALAISE (non-serious), outcome "unknown".  Additional information: Patient's past medical history was not reported. On an unknown date, the patient said she received her first shot and did fine with it stating, she hardly had any reactions. She said her glands were swollen and maybe a little tired and malaise for a couple days but nothing awful.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
mild case of  Shingles; rash in chest above sternum, fist size; itching; first dose around February of 2020; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 76-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis and COVID-19 VACCINE (COVID 19 VACCINE (MANUFACTURER UNKNOWN)) for prophylaxis.   Previously administered products included Covid Vaccine.   In February 2020, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix and COVID 19 VACCINE (MANUFACTURER UNKNOWN). On an unknown date, between 1 and 2 years after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced shingles, rash, pruritus and incomplete course of vaccination. The patient was treated with dermatologicals nos (Lotion Unknown) and hydrocortisone. On an unknown date, the outcome of the shingles, rash and pruritus were not recovered/not resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the shingles, rash and pruritus to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The patient received his 1st dose of Shingrix vaccine around February 2020 and he now had a mild case of Shingles. He stated that he received the first dose of Shingrix at his work site as they were also doing COVID-19 vaccinations, he received both Shingrix and COVID-19 vaccine at the same time. The patient did not recall which arm he received the Shingrix vaccine, but he stated he received both the COVID and Shingrix vaccine on the same arm. The patient stated that he had a mild case of shingles for approximately 1 month, in which he experienced rash and itching. The rash was located in the center of his chest above the sternum and it was about the size of a fist, he used medicated skin lotion and hydrocortisone ointment which eased the itching. The patient did not receive the second dose of Shingrix vaccine till the time of reporting, which led to incomplete course of vaccination. The reporter was given medical advice disclaimer and referred to health care professional. The patient had limited information. He stated he did not have a primary physician. The reporter did not consent to follow-up. It was unknown if the reporter considered the shingles, rash and pruritus to be related to COVID-19 vaccine.
Received vaccine around 5:00 pm. That night I had chills, a lot of soreness in my left arm (vaccination site) and tingling in my left hand. Slept terribly, very thirsty, woke up around 8:45 am, and went to restroom. While refilling water bottle, I got nauseous and started having tunnel vision. I thought this is probably what it feels like before people faint. The next thing I knew, I passed-out. I woke up probably a minute later in the bathtub with no recollection of how I got there but with major soreness on my side. I was very nauseous for the next few hours (and also terrified). Never fainted before and no fear of needles currently.
arm began to swell w/in a few hr;3 days later it started turning colors-yellow & red & swelling lasted about a month or more; Pella, IA hosp prescribed Augmentin, DPH & Tagamet;
One week after the vaccination a red rash developed at the site, about 3 inches in diameter.  It is still there, about as red, same size.  Rarely itches.
This RN with pre-existing ulcerative colitis was asked by her private physician how long she had to wait after her vaccination before taking steroids-she felt she could delay for awhile and went on vacation. Expected to recover.
A report was received from a health care professional on 11/13/2002 concerning a group of approximately 30-40 vaccinees between the ages of 70-80 years who inadvertently received subtherapeutic dose of Fluvirin between 10/20/2002-11/06/2002. Between 10/20/2002-11/06/2002 a group of approximately 30-40 vaccinees inadvertently received a sub-therapeutic dose of Fluvirin when the black line that encircles the syringe was utilized to expel air and prime the needle. There was insufficient information to determine the reporters causality assessment.
He got his vaccine, immediately where the needle went in he had a bruise and just stayed the same.  Then a few days later he started feeling stiffness and pain in his right neck and shoulder area.  He did not have any rash, fever or other symptoms.  He does still have the swelling at the injection site.  He has taken Aleve for the discomfort.  He has not called his doctor.   He is able to work, but is having the pain in the neck and the shoulder every day.
pt experienced severe dizziness and nausea. pt passed out. We called 911 and she was taken by EMT.
Chills; Significant back pain; Sore and swollen arm at injection site; Sore and swollen arm at injection site; Diffuse arthralgias; Explosive diarrhea; Fever of 102; This is a spontaneous report from a contactable physician (patient). A patient of unspecified age and gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EW0153), via an unspecified route of administration on 13Apr2021 at single dose for COVID-19 immunization. The patient's medical history included ongoing chronic allergic rhinitis. The patient's concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EP6955) administered via an unspecified route of administration on 22Mar2021 at single dose for COVID-19 immunization. The patient previously received fexofenadine hydrochloride (ALLEGRA) 180mg, once daily (QD) and azelastine hydrochloride, fluticasone propionate (DYMISTA) nasal spray at one spray, twice daily (BID) for allergic rhinitis. On early evening of 15Apr2021, the patient experienced fever of 102, chills, significant back pain, sore and swollen arm at injection site, diffuse arthralgias, and explosive diarrhea. The patient took 1000 mg acetaminophen and went to bed. Awoke in the morning of 16Apr2021 as much improved and afebrile. The patient recovered from the event fever on 16Apr2021 and was recovering from other events.  No follow-up attempts are possible; No further information is expected.
first shot was 2 weeks ago. Yesterday he tested positive for covid; first shot was 2 weeks ago. Yesterday he tested positive for covid; This is a spontaneous report from a Pfizer-sponsored program . A contactable consumer reported a male patient (Reporter's Father) of an unspecified age received first dose of bnt162b2 (lot number unknown), via an unspecified route of administration, on Jan2021 at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient had covid vaccine, first shot was 2 weeks ago. Yesterday he tested positive for covid. Inquiring how protected is he with vaccine. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 09Feb2021. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Suspected Vaccination failure; whooping cough; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received DTPa (Reduced antigen) (dTpa vaccine) for prophylaxis.   On an unknown date, the patient received dTpa vaccine at an unknown dose. On an unknown date, 3 years after receiving dTpa vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and whooping cough (serious criteria GSK medically significant). On an unknown date, the outcome of the vaccination failure and whooping cough were unknown.   It was unknown if the reporter considered the vaccination failure and whooping cough to be related to dTpa vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient got TPAP vaccination and 3 years later had whooping cough.  It was reported that the patient would never do that shot again. This case was considered as suspected vaccination failure, since the details regarding the number of doses and laboratory confirmation for whooping cough were not provided.
Nausea; Lethargy; Her body smells different; she "Developed reaction to sterling silver, electrolytes "bottomed out" and it took 2,5 days to balance; This is a spontaneous report from a contactable consumer (patient) via a Regulatory Authority. A female patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 17Jun2021 as a single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date in 2021, the patient experienced nausea, lethargy and she developed reaction to sterling silver, electrolytes bottomed out and it took 2,5 days to balance and felt her body smells different. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Dizziness, Fever, Left arm swollen with bubbled up injection area followed by intense Muscle inflammation from under armpit all the way to the chest/pectoral area.
The day after my shot around 11:30 AM I began to feel extremely tired while at work. I felt like I could not concentrate and I felt loopy. I felt like I wanted to lay on the floor and fall asleep. I went home around 12:15 and slept from 1pm to 5 am. The next day I felt out of it.  The day after my shot I had a large red lump on my arm in the area where I got my vaccine and it was very sore. This lasted a few days and the pain and redness went away.  Yesterday, 4/19/21, I woke up with a large red swollen circle around the injection site. It itches very bad and burns. The skin is very hot. Today on 4/20/21 a red ring appeared around the red circle. It is still very itchy and burning. The skin in this area is very hot. Only ice has helped with the pain.