chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Two weeks after the second dose, I started having intense arm pain at the injection site. It was as if I had just gotten the shot again, although my original symptoms had long subsided.  The pain woke me up in the middle of the night and I could feel it radiating down my arm. Over the counter pain medicine helped but the pain would come back after the medicine wore off. I sought medical attention because it was my left arm and I wanted to be on the safe side. The doctor was not sure was the cause was and thought it might be a nerve issue.  Because the pain was exactly what I experienced after the second shot, I feel certain that it was a carry over side effect.  The pain subsided within 24 hours and I haven't had any issues since then.
Patient stated it started to get red later the same day. Reaction became more pronounced the next day and included swelling, itching, and warm to the touch. Area affected included triceps to elbow.
This spontaneous report as a part of social media received from a Twitter user who refers to a female patient of unknown age. On an unknown date the patient was vaccinated with GARDASIL (lot number, expiration date, dose, route of administration and indication were not reported). It was reported that the patient had matching symptoms to those mentioned in the report with MARRS# 1401USA014506. It was reported that on unspecified date the patient finished the GARDASIL vaccine series, and her health went downhill from there. Her pain just kept getting increasingly worse and it was just spreading further and further throughout her body. It was reported that she has been in pain for years, she was visiting multiple doctors, who gave her pain remedy that did not work, they did not have any explanation for patient's severe back pain or leg pain. She stated that the pain would not go away. It was reported that she could not walk, she could not sleep, she could barely have friends. The patient was on a strict diet and vitamin regimen to cleanse her body. The outcome of the events was unknown. The relatedness between the events and GARDASIL was not reported. This is one of the several reports received from the same source. Upon internal review, the event she could not walk was considered to be disabling. Additional information is not expected.
This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 28May2021 (Lot number: EW0191) as dose 1, single for Covid-19 immunisation. Relevant medical history included: "Fibromyalgia" (unspecified if ongoing); "Chronic fatigue syndrome" (unspecified if ongoing); "Curvature of spine" (unspecified if ongoing); "Phlebitis in Varicose veins" (unspecified if ongoing); "Osteoporosis" (unspecified if ongoing); "extreme sensitivity to all medicines and vaccines" (unspecified if ongoing). Concomitant medication(s) included: AMBIEN. The following information was reported: PAIN IN EXTREMITY (non- serious) with onset 2021, outcome "recovering", described as "Soreness in my arm; I don't even pay attention to it/pain in my legs specially the calves so bad/the leg pain was very severe"; PARAESTHESIA (non-serious), outcome "recovering", described as "tingling in my hands, in my jaw/severe tingling"; PAIN (non-serious), outcome "recovering", described as "Weird Pain and it was frightening"; PAIN IN JAW (non-serious), outcome "recovering", described as "Jaw and one side of my head hurt; I got up and then other side of my head hurt; it was crazy"; GAIT DISTURBANCE (non-serious), DYSSTASIA (non-serious), outcome "recovering" and all described as "I couldn't even stand up for washroom and dress/couldn't stand up and walk"; ILLNESS (non-serious), outcome "recovering", described as "I am ill"; ANTIBODY TEST ABNORMAL (non-serious), outcome "unknown", described as "my antibodies were high they said, they didn't give if it is positive or negative, they said "3.3 H" (not clarified)"; INSOMNIA (non-serious), outcome "recovering", described as "Even hard to sleep"; HEADACHE (non-serious) with onset 28May2021, outcome "recovering", described as "first one side of my head hurt started immediately after the vaccine/the other side of my head hurt/head pain was very weird it was like just the right side of my head slip down with the center". Relevant laboratory tests and procedures are available in the appropriate section. No follow-up attempts are possible. No further information is expected. Sender's Comments: Linked Report(s): US-PFIZER INC-202100975961 similar report from same reporter.
Dose administered to 10 patients after more than 30days of storagein the fridge; Dose administered to 10 patients after more than 30days of storagein the fridge; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered to 10 patients after more than 30days of storagein the fridge) and PRODUCT STORAGE ERROR (Dose administered to 10 patients after more than 30days of storagein the fridge) in a 26-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Feb-2022, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered to 10 patients after more than 30days of storagein the fridge). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Dose administered to 10 patients after more than 30days of storagein the fridge). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered to 10 patients after more than 30days of storagein the fridge) and PRODUCT STORAGE ERROR (Dose administered to 10 patients after more than 30days of storagein the fridge) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided. No treatment information was provided.  Vials were stored in fridge since 22-Dec-2021
Pt developed a rash starting the day of the vaccine. No fever. Did not seek medical help.
TOOK  VIVOTIF WHILE ON DOXYCYCLINE; This spontaneous case (PVX2019-1399) report was received from a consumer on 31-May-2019. It describes a female consumer who "took Vivotif while on doxycline" She was receiving Vivotif for an unknown indication and doxycycline tablets (100 mg) for acne.  Case report: The consumer took Vivotif while on therapy with doxycline (100 mg). She took doxycycline daily for acne and it was a 3-month prescription.  Action taken with Vivotif and doxycline was not applicable.  The clinical outcome of the event was unknown.  Company's Comment: The causality of the event "took Vivotif while on doxycline" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took Vivotif while on doxycline" was considered as not applicable.
Nausea, dizzy, mild fever, some swelling--all of which increased to fever of 103.5F and severe swelling at site of injection with hives by 6pm on 10/15/2013 despite use of Benadryl and Ibuprofen.  Went to ER and started Prednisone 40mg--swelling and pain is mildly improving as of 10/17/2013.
The Moderna Covid-19 Vaccine, mRNA-1273 (PF) 100 mcg/0.5 mL IM Susp, Lot 046A21A on 3/22/2021. The patient experienced the following reaction(s) during the immediate   of observation: 2:12pm Patient c/o "dizziness, hot, and nauseous." VS BP 100/60, HR 47-60s, RR 20, O2 sat 98% on room air. Denies SOB or difficulty breathing. Patient reports history of bradycardia, migraine, and gastritis. Patient was treated/managed as follows:    2:22pm VS BP 98/60, HR 74, RR 18, O2 sat 98% on room air. Patient reports symptoms subsided. Patient given educational material regarding vaccine and advised to continue to self-monitor. 2:25pm Patient escorted to car by patients family.
Site: Swelling at Injection Site-Mild. Additional details: Patient has raised, fluid-filled blister at injection site. No arm pain. Patient has full range of motion with no discomfort. Advised him to use warm compresses. If doesn't get better within a day or two, to have it taken a look at by a doctor.
SUSPECTED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a consumer concerned multiple patients. 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: Unknown) dose, 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patients experienced suspected immunological vaccine failure. As per the reporter "Her physician told her that some of his patients who had the J&J vaccine did not show immunity to the spike and protein after being vaccinated on their antibody tests(negative antibody tests)." Laboratory data (dates unspecified) included: COVID-19 antibody test (NR: not provided) Negative (did not show immunity to the spike and protein). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of suspected immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with RA: 90000193688; Sender's Comments: V0: 20210931809-covid-19 vaccine ad26.cov2.s -suspected immunological vaccine failure . This event(s) is considered not related. The event(s) 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(s) than the drug. Specifically: SPECIAL SITUATIONS
FEVER; MUSCLE ACHE; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included covid-19.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805025, expiry: UNKNOWN) dose was not reported, administered on 21-MAR-2021 around 13 for prophylactic vaccination. No concomitant medications were reported. On JUL-2020, Laboratory data included: COVID-19 virus test (NR: not provided) positive. On 22-MAR-2021, the subject experienced fever. On 22-MAR-2021, the subject experienced muscle ache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever and muscle ache was not reported. This report was non-serious.
Information has been received from an approximately 55 year old female physician who in the end of August 2007, was vaccinated with a single dose of Zostavax (Oka/Merck).  Two weeks after vaccination, the physician developed a "minor case of shingles in the perineum" which were small and painful vesicles.  The patient treated herself and the vesicles were cultured to confirm that her condition was shingles.  At the time of this report the physician had recovered.  No further information was provided.  There was no product quality complaint involved.  Additional information has been requested.
extreme diarrhea; nausea; vomiting bile; feeling sick.; This is a spontaneous report from a contactable other HCP and a consumer from a program. A 61-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date (at the age of 61 years old) (Batch/Lot number was not reported) as single dose for COVID-19 immunization. The patient medical history was not reported. Concomitant medications included methotrexate, XELJANZ. The patient experienced extreme diarrhea on 22Aug2021, nausea on 22Aug2021, vomiting bile on 22Aug2021, feeling sick on 22Aug2021. Patient reported adverse event of extreme diarrhea, nausea, vomiting bile starting 22Aug2021, and lasted a few days. Patient reported negative COVID-19 test. Patient stated she stopped taking her Xeljanz and MTX for 1 week due to feeling sick. The outcome of the events was recovered in Aug2021.   No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected. Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event Diarrhea cannot be totally excluded. The case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the product is evaluated as part of 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 regulatory authorities, as appropriate.
1st vaccine administered on 3/09/21 by  Health Clinic was moderna, and a dose of pfizer administer on 3/31/21 at the  Community Center during a  Health Department COVID-19 vaccine Clinic event.
Pt reports immediately after getting this vaccine feeling heart racing; throat start to close & difficulty swallowing.   Pt was observed for apprx 1 hr following vaccination.  Pt was given several doses of Zyrtec with beneficial effect.  Pt reports she felt good enough to go to work after getting her vaccine.  Pt states several hours later the feeling of throat closure started again.  Pt reports for the next few days having to take OTC antihistamines for these s/sx.
Varicella Information has been received from a physician concerning her youngest child (child ahs 4 siblings) who was vaccinated SC with a 0.5ml dose of varicella virus vaccine live (Oka/Merck). In February or March 2005, the patient broke out with chickenpox during a school outbreak. Unspecified medical attention was sought. There was no product quality complaint. The reporter also indicated that the patient's 2 siblings also developed chickenpox. (WAES #0507USA00260 and WAES#0509USA2318). Additional information has been requested.
prednisone administered to her 7-year-old daughter interacts with the first dose; Little sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 7 year-old female patient received bnt162b2 (COMIRNATY), administration date 15Nov2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "postnasal drip symptoms" (unspecified if ongoing); "Allergy" (unspecified if ongoing). Concomitant medication(s) included: PREDNISONE ACETATE. The following information was reported: DRUG INTERACTION (non-serious) with onset 2021, outcome "unknown", described as "prednisone administered to her 7-year-old daughter interacts with the first dose"; PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "Little sore arm".  Additional information included: Prednisone was administered to her 7-year-old daughter interacted with the first dose of the Pfizer-BioNTech COVID-19 vaccine that she received a day before reporting. The mother explained due to her daughter's postnasal drip symptoms from her allergy, she gave her 10 ml of prednisone yesterday and 5 ml today. She explained her daughter had no reactions to the vaccines besides a little sore arm.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
recalled shingrix lot was given; recalled shingrixlot was given; This case was reported by a pharmacist via call center representative and described the occurrence of recalled drug administered in a patient who received Herpes zoster (Shingrix) (batch number 9lh3y, expiry date unknown) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced recalled drug administered and drug dispensing error. On an unknown date, the outcome of the recalled drug administered and drug dispensing error were unknown.  Additional details provided were as follows: Age at vaccination was not reported. Registered pharmacist reported that recalled Shingrix was administered to  patient, which led to recalled drug administered and drug dispensing error. The lot was recalled on 10th February 2021. Health care professional did not have any other details of date of administration. No other information of patient or vaccine available. Reporter did not consented to follow-up. This case was 1 of the 3 cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR226053:same reporter US-GLAXOSMITHKLINE-US2021AMR226054:same reporter
Fever ranging 101.9-102.7, Fussiness, Aching legs, Tired, loss of appetite, wouldn't bare weight, kept telling me "owie feet" and crying.
Starting with night of day 1 - fever, ache, pain, nausea, tiredness, headache, injection site painful Day 2 & 3, headache, nausea, tiredness, red welt on upper arm not at injection site (hot and tender) Day 4 - nausea and tiredness,red welt on upper arm not at injection site (hot and tender) Day 5 - nausea and tiredness, red welt on upper arm not at injection site (hot and tender)
The day after my first shot i got my period. I am regular as clockwork.  My period came a full week early. I have a short cycle, so it was late when it came the day before my second COVID shot. I am past child bearing years and do not want children, so reproduction is not a concern for me. But i know a lot of women who are in child bearing years and are concerned about their reproductive health with the vaccine. Many women i know have had their periods fluctuate due to vaccination.  from what i have read, this is just beginning to be looked into. Unfortunately, this should have been looked into in the very first trials performed. But i can understand how hard that would be to find women willing to do a trial that could potentially cause them to not be able to conceive. Only time will tell how the vaccine truly affects women's reproductive health. But what i can tell you is there will not be a large increase in women getting vaccinated until this issue has been shown to actually be throughly reseached. Just saying there appears to be no problems is not good enough when women talk and know there are problems.   There needs to be legitimate scientific study done to show that while the vaccine disrupts a cycle short term it has no long term effects. until that can be proven there will be continued vaccine hesitancy.
10 days ago pt recvd MMR/DTP/OPV/HIB & devel rash on face/arms 12MAY91; Fever 11MAY91; temp inc-possibly rxn to MMR;
Following Pfizer BioNTech COVID-19 Vaccine dose 1, patient complained of dizziness, nausea, and chills for about 20 minutes.  Patient was placed supine and offered fluids and crackers.  Symptoms improved. Vital signs taken and were stable.  Patient raised to sitting position and ambulated without difficulty.  She was observed in the clinic for 45 minutes after her vaccine was given and she was able to leave the clinic independently.  She was advised to call her primary care provider for any return of symptoms, and to report immediately to the emergency department if symptoms become severe.
1st covid19 vaccine from dose Pfizer/2nd covid19 vaccine from moderna; 1st covid19 vaccine from dose Pfizer/2nd covid19 vaccine from moderna; allergy is in the legs, especially in the right leg/allergy increased after the moderna vaccination; This spontaneous case was reported by a consumer and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (1st covid19 vaccine from dose Pfizer/2nd covid19 vaccine from moderna), PRODUCT ADMINISTRATION ERROR (1st covid19 vaccine from dose Pfizer/2nd covid19 vaccine from moderna) and HYPERSENSITIVITY (allergy is in the legs, especially in the right leg/allergy increased after the moderna vaccination) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.  Concomitant products included to treat cholesterol and CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) for an unknown indication.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Apr-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (1st covid19 vaccine from dose Pfizer/2nd covid19 vaccine from moderna), PRODUCT ADMINISTRATION ERROR (1st covid19 vaccine from dose Pfizer/2nd covid19 vaccine from moderna) and HYPERSENSITIVITY (allergy is in the legs, especially in the right leg/allergy increased after the moderna vaccination). At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (1st covid19 vaccine from dose Pfizer/2nd covid19 vaccine from moderna), PRODUCT ADMINISTRATION ERROR (1st covid19 vaccine from dose Pfizer/2nd covid19 vaccine from moderna) and HYPERSENSITIVITY (allergy is in the legs, especially in the right leg/allergy increased after the moderna vaccination) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medication were reported.
returned to clinic 1 1/2hr p/vax c/o scattered itching & hives;+ tenderness warmth & swelling @ site of inj;pt took DPH @ onset of sx;
I had a stuffy nose and scratchy throat on the 28th. I did a test on the 29th it was negative. I arrived home on the 30th I had chest congestion and trouble with congestion. On July 3, 2022, I went to the ER, I was having chest pain and trouble inhaling. I was given a EKG, x-ray. I developed a cough that MUCINEX helped with the cough. The cough lasted about three days total. The chest pain stopped after the visit to the ER was over. My nose did drain uncontrollably throughout the COVID-19. On the forth of July I had green discharge coming out of my tear ducts. I had a video visit with a doctor and she prescribed eye drops for me. I never had fever or fatigue. Just eye discharge, congestion and cough.
Pain in left side of head, hard to swallow, fever (99.0-101.9), chills, night sweats, lymphadenopathy, facial pain (left temple), L EOC erythemic, increased neutrophils.
Minutes after vaccination felt dizzy, vision got cloudy, and passed out into mom's arms. Awoke on the floor.
Friction rub noted during examination by cardiologist on May 14 2021. Patient had a history of intermittent tachycardia and chest discomfort for weeks prior.
Pt returns approximately 6 hours after injection with itchy swelling at injection site. 10 cm indurated hive like swelling on (L) deltoid. Treatment recommendations are ice, elevation, prednisone 40 mg qd x 5 days.
08/3/05 12:30 AM (night), baby in bed with mom. Baby had been running fever 101.4; treating with Tylenol through the day. Baby had severe seizure - eyes rolled back - stopped breathing. 911 called - quick response - immediately bagging child. Took to nearest hospital. 02 given in ER.  Information received from Medical records states otitis. msv
Patient received the Moderna COVID vaccine for their 1st dose and the Pfizer vaccine for their 2nd dose.