chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I noticed hives on patient's face. They were also all around the injection site, on his chest and back. We took him to the emergency room. The doctor gave him Benadryl and acted like we were overreacting. Anyway, he has continued to have hives off and on all day today (12/4/2009). I have been using oral Benadryl liquid and topical Benadryl spray. The hives go away for a while, then new ones show up. He is now getting them on his legs as well as upper body. He has had no breathing difficulty.
Stiff injected arm after 2nd vaccine; Sore injected arm after 2nd vaccine; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Stiff injected arm after 2nd vaccine) and INJECTION SITE PAIN (Sore injected arm after 2nd vaccine) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032M20A and 024M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Mar-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (Stiff injected arm after 2nd vaccine) and INJECTION SITE PAIN (Sore injected arm after 2nd vaccine). On 15-Mar-2021, MUSCULOSKELETAL STIFFNESS (Stiff injected arm after 2nd vaccine) and INJECTION SITE PAIN (Sore injected arm after 2nd vaccine) had resolved.            No concomitant medication was provided. No treatment information was provided.  Patient reported that the more she used the arm the better it got.   This case was linked to MOD-2021-380909, MOD-2021-380909 (Patient Link).
I had the booster on the 28th and saw the gynecologist for a routine visit on the 29th. She ordered a screening mammogram on 09/30/2021 along with a DEXA scan which was fine. They saw something that wasn't quite normal. On 10/15/2021, I had a follow up mammogram and ultrasound which an enhanced more detailed version. On 10/25/2021, I had a breast biopsy and then on 10/28/2021 and confirmed that it was cancer, they told me this on the 15th but by pathology I was told on the 28th. On November 11, I saw the surgeon, but no testing was done. I also had an MRI on 11/26/2021 to see if it had spread, but it did not. On 12/17/2021, I had a partial mastectomy with node biopsies. Took out 5 nodes. On 03/09/2022, I started radiation treatments. COVID tests were negative for procedures. The cancer was called "ER positive PR positive HER2 negative"
Chills with no fever from about 10pm on 4/29/21 to 2am 4/30/21
INCORRECT PRODUCT STORAGE; THE JANSSEN COVID 19 VACCINE WAS REFROZEN AND ADMINISTERED TO PATIENT; This spontaneous report received from a health care professional concerned a 48 year old female. 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, and batch number: 1821286 expiry: 20/MAR/2022) dose was not reported, administered on 09-SEP-2021 for prophylactic vaccination. Age at time of vaccination 48 years old. No concomitant medications were reported.  On 09-SEP-2021, the patient experienced the janssen covid 19 vaccine was refrozen and administered to patient. On an unspecified date, the patient experienced incorrect product storage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the the janssen covid 19 vaccine was refrozen and administered to patient and incorrect product storage was not reported. This report was non-serious. This case, from the same reporter is linked to 20220541180, 20220537683, 20220540524, 20220540688, 20220540570, 20220540324, 20220540611, 20220537341, 20220537356, 20220537444, 20220537532, 20220537548, 20220537688, 20220538149, 20220538210, 20220538238, 20220538292, 20220538297, 20220538316, 20220538411, 20220538425, 20220538428, 20220538437, 20220538480, 20220538573, 20220538666, 20220538693, 20220538758, 20220538890, 20220539045, 20220540420, 20220540435, 20220540474, 20220540536, 20220540642, 20220540816, 20220540853, 20220541506, 20220537507, 20220538480, 20220538146, 20220541085, 20220541401, 20220540765, 20220538347, 20220538379, 20220538627 and 20220540765.
Information has been received from a physician for varicella virus vaccine (Merck), a Pregnancy Registry product, concerning a female patient of approximately 36 year old with no pertinent medical history and no drug reactions or allergies. On 02-JUL-2015, the patient was vaccinated with the first 0.5 ml dose of VARIVAX (Merck) (lot # not reported) subcutaneously. Concomitant therapies included prenatal vitamins. The physician reported that on 20-JUL-2015, the patient was seen in the office and a urine pregnancy test was performed which came back positive. The patient's last menstrual period (LMP) as on 18-JUN-2015 and her estimated date of delivery (EDD) would be on 24-MAR-2016. The pregnancy outcome was pending. Additional information has been requested.
Patient received Monovalent Moderna 0.5ml blue cap purple label. Patient was intended to receive Bivalant Moderna 0.5ml blue cap gray label.
This spontaneous report as received from a other health professional refers to a female patient of unknown age. No information about medical history concurrent conditions and concomitant medications was reported. The reporter stated that on 30-APR-2014 the patient was vaccinated with expired ZOSTAVAX strength 0.65ml, lot # J001006 expiration date 24-APR-2014, route subcutaneous in the right arm. No adverse effects reported. The outcome of events reported is unknown. No product quality complaint was involved. Additional information has been requested.
Fever starting a few hours after for 48 hours. Almost unmovable arm with in 24 hours, turning to a large hot rash within 48 hours.
Blistering rash around left wrist and left hand/fingers and blistering rash on right wrist and side of right hand.
PAIN IN SHOULDER OF THE ARM VACCINATION WAS GIVEN. PATIENT STATED OVER PHONE CONVERSATION HE CAN NO LONGER ELEVATE ARM ABOVE HEAD.
Fever 102, body aches, chills, bad headaches.  Lasted 24 hours and started around the 15 hour mark after injection.  Took advice from my Primary Care and took Tylenol and IB to help ease the symptoms.
Patient presented with worsening fatigue and shortness of air that began Friday(1/15/21) after receiving COVID 19 vaccination. She has also had nausea, vomiting, and diffuse abdominal pain since that time. Patient has had a cough for last five days. Patient admitted to ICU for care on 1/17/2021.
Cough; On and off dizziness; Heavy sweating; This spontaneous case from the was received on 23-Nov-2020 from other health professional via The Agency (reference number: SEQW20-05390) and concerned a 65-year-old, male patient.  The patient's medical history and concomitant medications were not reported.  On 20-Nov-2020, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, mf59; dose: 0.5 ml, route of administration: intramuscular and anatomical location: left arm) for influenza prophylaxis. The batch number reported was 279812 and expiry date was 30-Jun-2021.  On the same day, 30 minutes after receiving Fluad Quadrivalent, the patient developed heavy sweating. The patient also had on and off dizziness.  On 23-Nov-2020, sweating returned as well as a cough.  At the time of initial reporting on 23-Nov-2020, the patient had not recovered from the events, reported as not improved.  The reporter did not provide a causality assessment.   The reporter assessed the case as non-serious.  Company comment: A 65-year-old patient was vaccinated with Fluad Quadrivalent. On the same day, 30 minutes after receiving Fluad Quadrivalent, the patient developed hyperhidrosis and dizziness. Three days later the patient also experienced cough. Causality is assessed as possibly related for all events. Causal role of the suspect vaccine is assessed as possibly related for all events.; Sender's Comments: A 65-year-old patient was vaccinated with Fluad Quadrivalent. On the same day, 30 minutes after receiving Fluad Quadrivalent, the patient developed hyperhidrosis and dizziness. Three days later the patient also experienced cough. Causality is assessed as possibly related for all events. Causal role of the suspect vaccine is assessed as possibly related for all events.
Injection site arm pain; This is a spontaneous report received from a contactable reporter (Pharmacist).  A patient (no qualifiers provided) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administered in arm (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "Injection site arm pain".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Child upset, crying flailing could not comfort 15 minutes. Gave Motrin and she fell asleep. Later she was in car seat and was disengaged, disoriente, trembling head bobbing and shaky. Her eye turning out to the side.
20-30 minutes after vaccine patient returned to observation center complaining of difficulty breathing and constriction in throat.  Vitals stable, pulse ox 100%, pharynx clear without edema and no wheezing.  However she was quite distressed, becoming diphoretic, and stating that breathing and throat constriction was worsening. She was treated with 0.3 mg epinephrine IM left thigh and 25mg Benadryl left deltoid.  After treatment breathing improved, throat constriction resolved, and she felt a rapid heart rate and dizziness.  These also gradually improved and she was discharge home with her husband, with prescriptions for famotidine, loratadine, to not take metformin today, and strict ED precautions for recurrence of breathing or throat constriction symptoms.
urticaria; very large, red, itchy whelps all over her body kind of like an immune response to it and it hasn't stopped.; very large, red, itchy whelps all over her body kind of like an immune response to it and it hasn't stopped.; This is a spontaneous report from a contactable consumer or other non hcp. A 56-years-old female patient (patient was not pregnant at the time of vaccination) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EW0182, Expiry date: unknown), via an unspecified route of administration, administered at an unspecified anatomical location on 17May2021 10:30 (age at vaccination was 56 years) as dose 2, single for COVID-19 immunization. The patient's medical history included none from an unknown date. The patient did not have any known allergies. The patient did not receive any concomitant medications or other medications in two weeks. The facility where the most recent COVID-19 vaccine was administered was Pharmacy or Drug Store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: EW0171, Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on 20Apr2021 (age at vaccination was 56 years) as dose 1, single for COVID-19 immunization. On 01Jun2021 the patient experienced urticaria and on Jun2021 the patient experienced very large, red, itchy whelps all over her body kind of like an immune response to it and it hasn't stopped. Patient visits Doctor or other healthcare professional office/clinic visit. Patient received treatment as Benadryl and Claritin for the adverse events. Therapeutic measures were taken as a result of urticaria and very large, red, itchy whelps all over her body kind of like an immune response to it and it hasn't stopped. The outcome of the events was not recovered.  Follow-up attempts have been completed and no further information is expected.
Pt recv vax. Subsequently pt devel chickenpox. Brother also reported WAES98021925
Around 10 pm I felt chills over my entire body. About an hour later, a felt a warm sensation enter my body and then I felt feverish and sweats. I was extremely exhausted and couldn't get up out of bed for about 36 hours after that.
pt recv vax 21JAN98 & 23JAN98 pt exp inj site pain, swelling  4 inches of redness @ the site;
Two weeks post vaccination, pt's mother stated that the pt was listless and had a "high fever for several days." No other symptoms noted. Child recovered from further problems.
Patient took home test on 12/28, it was positive. She was ill with a fever for about a week, per patient. Patient has SOB and chest pain intermittent, is being treated for suspected lung cancer.
Rhabdomyolysis with CK of 65,000 approximately 4 weeks after 2nd COVID 19 vaccination.  Admitted to hospital for 3 days for fluid resuscitation, admitted with abnormal labs to include liver, kidney, urinalysis, and CK.  Labs back to normal within 3 weeks of hospital discharge.  Vaccination Dates:  Dose 1: 30 Dec 2020 Dose 2: 20 Jan 2021
This spontaneous report was received from a registered nurse and medical assistant and refers to a 13-month-old male patient. The patient's pertinent medical history, concurrent conditions, concomitant medications, past drugs and drug allergies were not reported. On 19-SEP-2017, the patient was vaccinated with improperly stored M-M-R II (lot # M034387; expiry date: 19-JUL-2018) (dosing details were not provided) for prophylaxis. Temperature excursion details of the vaccine were not provided. This is one of the several reports received from the same source. Sender's Comments: US-009507513-1709USA008861: US-009507513-1710USA013424: US-009507513-1710USA013470: US-009507513-1710USA013465: US-009507513-1710USA013440: US-009507513-1710USA013468: US-009507513-1710USA013442: US-009507513-1710USA013445: US-009507513-1710USA013460: US-009507513-1710USA013463: US-009507513-1710USA013464: US-009507513-1710USA013438: US-009507513-1710USA013439: US-009507513-1710USA013450: US-009507513-1710USA013430: US-009507513-1710USA013469: US-009507513-1710USA013467: US-009507513-1710USA013435: US-009507513-1710USA013434: US-009507513-1710USA013432: US-009507513-1710USA013428: US-009507513-1710USA013437: US-009507513-1710USA013441: US-009507513-1710USA013443: US-009507513-1710USA013444: US-009507513-1710USA013446: US-009507513-1710USA013447: US-009507513-1710USA013448: US-009507513-1710USA013436: US-009507513-1710USA013449: US-009507513-1710USA013451: US-009507513-1710USA013452: US-009507513-1710USA013454: US-009507513-1710USA013455: US-009507513-1710USA013456: US-009507513-1710USA013457: US-009507513-1710USA013458: US-009507513-1710USA013459: US-009507513-1710USA013461: US-009507513-1710USA013462: US-009507513-1710USA013466: US-009507513-1710USA013427: US-009507513-1710USA013471: US-009507513-1710USA013472: US-009507513-1710USA013473: US-009507513-1710USA013474: US-009507513-1710USA013475: US-009507513-1710USA013476: US-009507513-1710USA013425: US-009507513-1710USA013433: US-009507513-1710USA013423: US-009507513-1710USA013040: US-009507513-1710USA013426: US-009507513-1710USA013429: US-009507513-1710USA013431: US-009507513-1709USA008666: Original Case: 1709USA008666; US-009507513-1710USA014650: Original Case: 1710USA014649;  US-009507513-1710USA014651: Original Case: 1710USA014649; US-009507513-1710USA014649: Original Case: 1710USA014649.
Only received the first dose of Shingrix in 2019; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 59-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of no adverse event (received 1st dose on an unknown date in 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional information was provided as follows: The case was reported by patient's wife. The age at vaccination was not applicable for this report. Till the time of reporting, patient did not received 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter declined to provide health care professional information. The reporter did not consent to follow up. This case is linked to case US2021112517 reported by same reporter for different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021112517:Same reporter. Wife's case.
Redness and tender from hip to knee around shot site. The follow up states child has developmental delays.
Right arm (upper) "golf ball" sized hard lump. Sore for 7-10 days. Lump persisted 7-10 days.
Recipients received underdose of 0.25 Moderna Bivalent Booster/ wrong dose for Bivalent Vaccine booster dose (underdose).; No adverse event; This spontaneous case was reported by a physician and describes the occurrence of ACCIDENTAL UNDERDOSE (Recipients received underdose of 0.25 Moderna Bivalent Booster/ wrong dose for Bivalent Vaccine booster dose (underdose).) and NO ADVERSE EVENT (No adverse event) in an elderly patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, 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 an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (Recipients received underdose of 0.25 Moderna Bivalent Booster/ wrong dose for Bivalent Vaccine booster dose (underdose).) and NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Recipients received underdose of 0.25 Moderna Bivalent Booster/ wrong dose for Bivalent Vaccine booster dose (underdose).) 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 ACCIDENTAL UNDERDOSE (Recipients received underdose of 0.25 Moderna Bivalent Booster/ wrong dose for Bivalent Vaccine booster dose (underdose).).    No concomitant product reported by reporter.  It was reported that 100 patients were administered an invalid dose of Moderna COVID-19 bivalent booster. The nurse had no standing order other than what they had for second booster, when administering bivalent boosters, so they assumed same dose as second booster and administered 0.25mL to uncompromised adults.  This case was for one of the patient among the 100 patients who were administered an invalid dose of Moderna COVID-19 bivalent booster.   It was reported that CDC had recommended to revaccinate the patients with full dose of 0.5mL.  No treatment medication reported by reporter.
Patient received 4th dose of pfizer booster on 1/10/22. Upon checking database for first time he did not come up as registered for any vaccinations. Upon entry into database- found spelling of his name was not correct leading to him getting 4th dose of vaccine.    No adverse events noted.
BULGE IN BACK; COLONOSCOPY SHOWED INFLAMMATION BUT NOT MAJOR; SICK TASTE IN MOUTH; WEIRD PATCHES OF SKIN THAT WERE FLAKY ON ARMS AND BACK OF HANDS; GUT PAIN; RED SPOTS ON HANDS THAT WERE LIKE PSORIASIS; RASH PSORIAFORM; STABBING PAIN IN SIDE/HURTS WHEN GOES TO THE BATHROOM; BACK PAIN; STRESS; NOT FEELING WELL/FELT SICK; ELEVATED TEMPERATURE; FELT NAUSEOUS; HEADACHE; FELT TIRED AND RUN DOWN; This spontaneous report received from a patient concerned an adult male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported, per procedure, no follow-up will be requested for this case. Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, route of admin, and batch number were not reported) 40 mg, frequency, and therapy dates were not reported for moderate to severe adult crohn's disease, and ankylosing spondylitis. Concomitant medications included alprazolam for drug used for unknown indication. On an unspecified date, the subject experienced bulge in back, colonoscopy showed inflammation but not major, sick taste in mouth, weird patches of skin that were flaky on arms and back of hands, gut pain, red spots on hands that were like psoriasis, rash psoriaform, stabbing pain in side/hurts when goes to the bathroom, back pain, stress, not feeling well/felt sick, elevated temperature, felt nauseous, headache, and felt tired and run down. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) Elevated, COVID-19 virus test (NR: not provided) Negative, Colonoscopy (NR: not provided) Not major inflammation, and Skin biopsy (NR: not provided) Negative for cancer, Negative for cancer. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from bulge in back, felt tired and run down, weird patches of skin that were flaky on arms and back of hands, gut pain, elevated temperature, back pain, stress, and headache, and the outcome of not feeling well/felt sick, colonoscopy showed inflammation but not major, sick taste in mouth, felt nauseous, red spots on hands that were like psoriasis, rash psoriaform and stabbing pain in side/hurts when goes to the bathroom was not reported. This report was non-serious.
Fever; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) and HEADACHE (Headache) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).   On 25-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jan-2021, the patient experienced PYREXIA (Fever) and HEADACHE (Headache). On 26-Jan-2021, PYREXIA (Fever) and HEADACHE (Headache) had resolved. Not Provided          No concomitant medication use was provided by the reporter. Treatment of events was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: AE contact Information Updated
Red and swollen left arm - hot to touch - very painful - about 6-7". MD treating with Prednisone.
severe: chills, ague, fever, organ pain, migraines, random systemic muscle tremors, fatigue, tachycardia, sudden loss of blood pressure, near syncopy.
large hot, hard, raised, welt below injection site approx 3" x 3". Fuzzy, tired feeling.
the day p/receiving flu shot, became very weak; appetite is diminished & pt is having lower gastro intestinal tract discomfort (gas pains); last few wks, has had low grade fever 99.6;