chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Atrial flutter; Elevated heart rate (120-125); Whole left arm from shoulder to elbow became swollen; Whole left arm from shoulder to elbow became red; Dizziness; foggy headache; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 10-Sep-2021 and was forwarded to Moderna on 10-Sep-2021.    This spontaneous case was reported by a consumer and describes the occurrence of ATRIAL FLUTTER (Atrial flutter), HEART RATE INCREASED (Elevated heart rate (120-125)), PERIPHERAL SWELLING (Whole left arm from shoulder to elbow became swollen), ERYTHEMA (Whole left arm from shoulder to elbow became red) and DIZZINESS (Dizziness) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Tachycardia (was hospitalized for that but she was told that it was due to severe anemia (HR then reached 199)).   On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Jan-2021, the patient experienced HEADACHE (foggy headache). On 15-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HEART RATE INCREASED (Elevated heart rate (120-125)), PERIPHERAL SWELLING (Whole left arm from shoulder to elbow became swollen), ERYTHEMA (Whole left arm from shoulder to elbow became red) and DIZZINESS (Dizziness). On an unknown date, the patient experienced ATRIAL FLUTTER (Atrial flutter). The patient was treated with PARACETAMOL (TYLENOL) on 18-Jan-2021 for Tachycardia, at an unspecified dose and frequency; METOPROLOL for Adverse event, at a dose of 50 mg,1 1/2 tab AM 1 tab in the evening and WARFARIN SODIUM (COUMADIN) for Adverse event, at an unspecified dose and frequency. At the time of the report, ATRIAL FLUTTER (Atrial flutter) had not resolved and HEART RATE INCREASED (Elevated heart rate (120-125)), PERIPHERAL SWELLING (Whole left arm from shoulder to elbow became swollen), ERYTHEMA (Whole left arm from shoulder to elbow became red), DIZZINESS (Dizziness) and HEADACHE (foggy headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Feb-2021, Electrocardiogram ambulatory: abnormal (abnormal) atrial flutter. On an unknown date, Heart rate: 120-125 heart beats per minute (High) elevated heart rate (120-125).         No concomitant medication is provided On 2021, Patient had EKG, No results were provided  Patient was monitored for 14 days in Holter monitor and it was reported that she would be getting 2D Echocardiogram. She was monitored by an emergency doctor and the vaccine provider after she was given the 2nd dose.   This case was linked to MOD-2021-315374 (Patient Link).
7/26/99 pt devel herpes zoster on lt back; 7/28 full blown zoster C7 lt back to thumb; fever 102.6;some diarrhea;
Immediately following vaccine area was swollen, red, & sore right arm. 3:00 am - fever 103 degrees, severe headache at back of head/neck, nausea, vomiting, chills, rapid heartbeat, paleness, weak. 8:00 am - vomiting stopped, fever 100 degrees, headache, fast heart, pale, joint pain all over body, nausea. Arm swollen & red, nausea, joint pain on right side of body lasted till 6/26. Dr prescribed PHENERGAN.
She developed a slight cough and slight headache on 3/17/22. She went to daycare today (3/18/22)and developed hives on her legs and neck. No known exposure to any food allergens. Her tonsils are red and swollen, she was tested for strep; the rapid strep is negative and throat culture is pending.
Patient was given vaccine. A couple of minutes after the vaccine, during observation period, patient was in and out of consciousness, feeling faint, and was very pale. Fire rescue was called and all vitals were fine. Patient opted out of leaving with fire rescue and decided to go home.
No signs or symptoms of an adverse event. Incorrect diluent was used to reconstitute HIB vaccine.
Information has been received from a RN concerning a male who on 02Jun04 was vaccinated with a dose of varicella virus vaccine live. Subsequently the pt experienced chickenpox. It was also noted that the pt's sister experienced an adverse event (WAES0602USA00389). Additional information has been requested.
volvulus; volvulus and needed surgery followed by further ischemia; This is a spontaneous report from a contactable physician. An 86-year-old female patient received her first single dose of BNT162B2 (Pfizer-BioNTech Covid-19 vaccine) intramuscularly on 19Jan2021 for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had no known allergies. The patient developed volvulus and needed surgery followed by further ischemia and at end of life. The events onset date reported as 27Jan2021. Patient had 3days hospitalization and died eventually. It was unknown if an autopsy was performed. Information about lot/batch number has been requested.; Sender's Comments: Very limited information was provided in this report.  No relevant information regarding the clinical course of the events, the patient's underlying medical conditions were mentioned. Based on the information currently available, lacking any other alternative explanations as so far, the reported volvulus and Intestinal ischaemia are managed as related to COVID-19 vaccine, BNT162B2, for reporting purpose, only.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate.; Reported Cause(s) of Death: volvulus; ischemia
Little pain in the arm; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain in arm (Verbatim: Little pain in the arm). The outcome of the pain in arm was not reported.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.     It was unknown if the company considered the pain in arm to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 14-JUN-2023 This case was reported by a patient via interactive digital media. The patient received two doses of Shingles vaccine and nothing happened. Patient had only a little pain in the arm. The follow-up could not be possible as no contact details were available.
The one on May 5th he had quite a bit of reaction, the achy muscles, headache, nausea and even a little bit of the blurry vision; The one on May 5th he had quite a bit of reaction, the achy muscles, headache, nausea and even a little bit of the blurry vision; The one on May 5th he had quite a bit of reaction, the achy muscles, headache, nausea and even a little bit of the blurry vision; The one on May 5th he had quite a bit of reaction, the achy muscles, headache, nausea and even a little bit of the blurry vision; This is a spontaneous report received from a contactable consumer (patient's wife). A male patient of an unspecified age received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration on 05May2021 as 1st dose, single dose and received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration on 27May2021 as 2nd dose, single dose for COVID-19 immunization. Patient medical history and concomitant medications were not reported. Patient's wife stated that her husband and she herself received the Pfizer Vaccine, their first one on 05May2021 and second one on 27May2021. Now her husband when had the one on 05May2021 he had, quite a bit of reaction, the achy muscles headache nausea and even a little bit of the blurry vision. And within a day, she would say probably in 2 days he was feeling better. Now on the 27May2021, the second dose that they got, he had a little bit less the first couple of days achy muscles but it then, they were going on 11 days now since that shot and today (07Jun2021) he is starting to feel very nauseated, achy muscles again, headache chills. The outcome of the events was recovering.   Information on the lot/batch number has been requested.
This spontaneous report was received from a pharmacist, concerning a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant therapies, drug reactions or allergies were unspecified by reporter. On an unknown date, the patient was vaccinated with ZOSTAVAX (strength, dose, dose number, route, anatomical location, lot number and expiration date were unspecified). On an unknown date the patient experienced "redness and blistering from elbow to armpit". It was unspecified if a treatment was given for the events. The outcome of the events was reported as not recovered. The causality of the events was not reported. This is one of two reports received from the same reporter. Additional information has been requested.
Patient received Moderna COVID vaccine on 1/20/21, 2/15/21, 11/23/21, and Moderna bivalent COVID vaccine on 1/31/23. On 3/3/23, patient admitted to our inpatient facility (med/surg unit) with acute hypoxic respiratory failure, COVID pneumonia, and leukocytosis. Patient discharged home on 3/8/23.
Headache Positive COVID-19 diagnosis on 3/31/2021 Narrative:  Other Relevant History:
Erythema and induration Left arm 3rd day after shot given. Painful resolving with conservative prescription.
I did not feel anything right after the Covid 19 vaccine shot, but around 2:00 am in the early morning of 11/18/2021, about ten hours after the shot, the needle site of my left arm started to feel sore, and my chest around my heart started to feel extremely tight, besides it felt like a warm stream of fluids came upon my heart, and I had extreme shortness of breath. I am still thinking these days if the warm stream of fluids was my blood, and if my heart was bleeding a little bit.
I woke up at about 3 in the morning on November 1 and had a pain across my upper chest. I got out of bed and walked around for a bit and it went away. I went back to bed and a minute later it came back. I got back up again and sat on the couch for 5 minutes then went back to bed. I woke up later that day and felt fine, and I did some work, ate dinner, and walked the river front with my wife. The same pain hit me at this point and I sat down and it went away. We walked another two blocks and it happened again. We continued to walk and my wife noticed I was really out of breath. When we got up the hill, after a short distance, the pain hit me again and I told my wife we may need to get help. My wife took me to the emergency room and they did some blood work and an EKG. After two hours, they determined they needed to transfer me to another hospital because they were concerned. When I got there, the heart specialist said they would need to do a catherization. They took me down about 10AM to their operation room and they did the catherization and found a blockage. It was a 90% blockage in one artery and inserted a stent. Everything went fine and they released me November 3 and they noted that I was fine and under no other restrictions. I was in perfect shape and health and I went for a walk later that evening. I just need to be careful with my right arm because of the catheterization insertion. Otherwise, I'm doing fine. They did note that my cholesterol was fine with the blood work. I did also talk to my neighbor earlier today and he noted that he had seen me a week prior to this event working in the yard and noticed that I was more out of breath than usual.
adult patient was administered a pediatric dose of Havrix; adult patient was administered a pediatric dose of Havrix; This case was reported by a other health professional via call center representative and described the occurrence of underdose in a adult male patient who received HAV (Havrix pediatric) for prophylaxis.   On 2nd June 2022, the patient received Havrix pediatric. On 2nd June 2022, unknown after receiving Havrix pediatric, the patient experienced underdose and adult use of a child product. On an unknown date, the outcome of the underdose and adult use of a child product were unknown.   Additional Information: GSK Receipt Date: 2-Jun-2022 Reporter's Comments: Healthcare provider reported an adult patient was administered a pediatric dose of Havrix. The event occurred at a different facility and reporter did not have any of the patient details, or lot number or expiration date of the dose administered. The reporter believed the patient was male. The reporter consented to follow up. Additional Supportive Information: The adult patient was administered a pediatric dose of Havrix on 2nd June 2022, which led to underdose and adult use of a child product
SUSPECTED MENINGITIS; ASTHMA; COULD BARELY WALK; DEHYDRATION; LEG PAIN; This spontaneous report received from a consumer concerned a female of unspecified age. 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: Unknown, and expiry: UNKNOWN) dose was not reported, 1 total, administered on 13-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 27-APR-2021, the patient went to the hospital due to headaches, and was hospitalized. The doctors were suspecting meningitis (but reports that the patient is current in that vaccine). The patient had a Covid-19 and plaque check at the hospital. The patient was discharged from the hospital on 30-APR-2021. The patient was hospitalized for 3 days. The patient had followed up with Primary Care Provider and was having difficulty breathing, asthma, and wheezing. The patient received the nebulizer treatment and felt better. The patient could barely walk, did not think it was covid related. The Primary Care Provider thought that she could be dehydrated, however the patient kept drinking fluids and reported still not herself The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from asthma, and the outcome of leg pain, suspected meningitis, could barely walk and dehydration was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender's Comments: V0: 20210504395-Covid-19 vaccine ad26.cov2.s-Suspected Meningitis, Asthma . These events are considered unassessable. The events has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the events.
Student came to nurses office from lunchroom with c/o stomachache. Axillary temp 101.2. Parent notified, Tylenol given. Parent picked student up and took to family doctor.
History was obtained from the child's father, who did not witness the event.  Zeth received DTaP, Hep A, influenza, and varicella vaccines on 12/12/07 at a routine well child exam.  On 12/13/07, while at school, he reportedly had a seizure-like episode involving unresponsiveness, flushing, and eyes rolling back which lasted approximately 2 minutes.  The child appeared normal immediately after the event.  The child has a strong family history of seizure disorders (father and paternal uncles with poorly controlled seizures).  The child was brought to the ER several hours later where he appeared well.  Laboratory evaluation at that time was normal.
After receiving the vaccine, the patient went to the bathroom and had large vaginal discharge of blood. Patient is currently on her period but states it was unusual for her cycle
Initial and follow-up information has been received from a licensed practical nurse concerning a patient who on 07-NOV-2007, was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (Lot# 658075/0962U). Subsequently, the patient experienced redness and swelling below the injection site. The area was also raised. It was reported by the nurse that the adverse event required a medical intervention. The patient was seen in the office and was given a prescription for an antibiotic. The patient was also prescribed naproxen (NAPROSYN), 375mg, twice a day. The whole arm below the elbow was wrapped in a bandage and ice was applied to the arm. It was reported that the patient was not hospitalized. The patient recovered on an unspecified date. The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released by the regulatory agency. Additional information has been requested.
Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: pt stated initially with the injection she felt the end of her tongue tingling and then a feeling throughout the body. it lasted about 10 minutes but subsided. she did not have any SOB/throat closing/ or anything needing an epi-pen. pt stayed for 45min to observe and she felt fine to leave.
Red hives on left hip, cheek, eye lid and nose; Painful arm; Red around injection spot; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old non-pregnant female patient received first dose of BNT162b2((PFIZER-BIONTECH COVID-19 MRNA vaccine; Lot number-ER2613) via an unspecified route of administration in the left arm on 22Mar2021 at 14:00 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. Medical history included cancer 13 years ago. The patient had a history of allergy to penicillin. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient did not receive medications within 2 weeks of vaccination. On 22Mar2021 at 20:00, the patient had experienced painful arm and redness around injection spot. On 23Mar2021 in the second day morning, the patient had red hives first on left hip, then on cheek, eye lid and nose in the afternoon. No therapeutic measures were taken. Adverse event resulted in emergency room/department or urgent care. The clinical outcome of the events painful arm, red around injection site and red hives on left hip, cheek, eye lid and nose were not resolved at the time of report.  No follow-up attempts are needed. No further information is expected.
From about 10:30-11:30 patient was nauseous, dizzy, wheezing, had trouble breathing & was pale with black rings under eyes. Gave him Benadryl and he was fine within an hour.
Numbness of hands, legs, began 18-20 hrs post vaccines given. Seen in ER parent told that lymphocytes were low. Recovered in 3 days.
The patient had been administered vaccine that had been storage at temperature excursion. The temperature excursion was 47 to 55 F. It is about 2 hours out of recommended  ranges.
Immunization place Friday 12/9/16. Child spiked 102 temp 1 am Saturday 12/10/16. Taken to ER no other S/S of infection or illness.
Pain in right leg, shaky leg, limping, fever to 102F. Symptoms are subsiding by 3/1/01. Last temperature was on 2/27/01.
Day of vaccination, approximately 8pm, patient developed fever, chills, dizziness, injection site itching, redness swelling. Patient reports took TYLENOL PM Extra Strength that night. Next day continued to have symptoms. Day 2 post vaccination symptoms resolves.
Toe nail growth slowed and stopped.  Toe nails became crusty and fell off within months of vaccination.  As of 01/12/2022 the toe nails remain gone with no recovery.
devel chickenpox 18APR97;pt recv vax 24AUG95;
Chills, body aches, diarrhea about 24 hours after vaccine. Cough, severe headache, temp of 100.0 started about 36 hours after vaccine and are still present
A third dose of Shingrix was given on accident. When speaking to the patient, the day after her vaccination, she reports a fever of 100.5 through the evening and night. Fever was gone by morning. She also reports pain at injection sight, starting a couple of hours after receiving vaccine and still has arm pain the day after. She has taken ibuprofen to help with the pain.
Pt was given KINRIX Dtap/IPV at 11 yr old Check up instead of Tdap BOOSTRIX.
Donor sypmtoms on 09/29/2023 were chills, fatigue, muscle and joint pain.
Pt complained of feeling dizzy and was diaphorectic, post vax. Pt's color was pale. Pt assisted to lie down and vital signs taken. Pt given coca-cola and rested for about 15 minutes and left without problems. Seen Saturday and dx'd with vasovagal reaction.
Vaccine was administered by Health & Human Services, 1st dose on 2/11/2021 and 2nd dose on 3/4/2021 (both vaccine at 3:00 PM).  Shingles later developed on the left arm as well as respiratory problems.  Visit to regular GP on 4/22/2021 resulted in RX for Valacyclovir 1GM tablets, methylprednisolone tablets USP dosepak 4 mg, Breztri inhaler to accompany Albuteral inhaler.  Currently on day 4 of 7-day regimen.  Breathing is vastly improved and shingles are drying out and clearing up.  Recovery progressing and ongoing.
Loss of appetite; mild stomach ache; disrupted sleep pattern sleep 10 hours a day (9/12/21) Severe depression (until 9/11; disrupted sleep pattern sleep 10 hours a day (9/12/21) Severe depression (until 9/11; Interchange of vaccine; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (Loss of appetite), ABDOMINAL PAIN UPPER (mild stomach ache), DEPRESSION (disrupted sleep pattern sleep 10 hours a day (9/12/21) Severe depression (until 9/11), SLEEP DISORDER (disrupted sleep pattern sleep 10 hours a day (9/12/21) Severe depression (until 9/11) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination.    Co-suspect product included non-company product (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.    Concurrent medical conditions included Hypertension (High blood pressure) and Allergy (Severe allergy with anaphylaxis).   On 06-Mar-2021, the patient started (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On 27-Mar-2021, (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) dosage was changed to 1 dosage form. On 26-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Aug-2021, the patient experienced DECREASED APPETITE (Loss of appetite) and ABDOMINAL PAIN UPPER (mild stomach ache). 26-Aug-2021, the patient experienced DEPRESSION (disrupted sleep pattern sleep 10 hours a day (9/12/21) Severe depression (until 9/11), SLEEP DISORDER (disrupted sleep pattern sleep 10 hours a day (9/12/21) Severe depression (until 9/11) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine). On 26-Aug-2021, INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine) had resolved. On 12-Sep-2021, DECREASED APPETITE (Loss of appetite) and ABDOMINAL PAIN UPPER (mild stomach ache) had not resolved and DEPRESSION (disrupted sleep pattern sleep 10 hours a day (9/12/21) Severe depression (until 9/11) and SLEEP DISORDER (disrupted sleep pattern sleep 10 hours a day (9/12/21) Severe depression (until 9/11) was resolving.        No concomitant medications were reported. No treatment medications were mentioned