chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pain and swelling in hands-LT ring finger enlarged greatly, surgery 1/15/03 to remove growth attacking both pulley sneaths-growth looked like raw oyster and no odor-attempt to culture for mycobacterium-now pt forfinger, Lt thumb and Lt toes swollen and painful. Medical Records received on 1/07/2004 states subchondrial cyst.
feeling a bit hostile; nausea; A spontaneous report was received from a consumer concerning a male patient who received Moderna's COVID-19 Vaccine, and who experienced nausea and feeling a bit hostile.   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On 22 Dec 2020, approximately ten minutes prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (batch unknown) intramuscularly for prophylaxis of COVID-19 infection.    On 22 Dec 2020, the patient felt nauseous after receiving the vaccine. Treatment information was not provided.   On 24 Dec 2020, the patient started feeling hostile.  Action taken with mRNA-1273 in response to the event was not reported.    The outcome of the events nausea and feeling a bit hostile was unknown.; Reporter's Comments: This case concerns a male of unknown age who experienced a NS unexpected event of anxiety and NS expected events of nausea.  Event onset occurred 10 minutes after the first dose of mRNA-1273. Treatment not reported. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Coronary artery bypass grafting x4 - left internal mammary artery grafted to LAD and reverse saphenous vein grafts placed to diagonal, obtuse marginal, and right coronary arteries on cardiopulmonary bypass. Hospital admission within 60 days of receiving the COVID vaccine.
Post-Medication Assessment performed by LPN at 4:13 PM. Adverse Reaction - After shot, pt stood up and needed to sit back down because he felt like he was going to faint, he then had a "stiffening event" but did not pass out. Monitored by Dr. and released after monitoring.
Pt recvd 3rd dose of vax 16OCT92 & exp dizziness, h/a, hot flashes; seen in ER; BP enroute to hosp was 110/100; had sore throat & upset stomach;
Dose 1 1/7/2021 Moderna Lot # 026L20A Pt die d  in the hospital
This spontaneous report as received from a physician refers to a 58 years old male patient with pneumococcal. The patient's medical history included labile hypertension. The patient was vaccinated with lot # (1947AA), 1 DF PNEUMOVAX 23 on 04-OCT-2012. No other co-suspects were reported. No concomitant medications were reported. On 04-OCT-2010 the patient experienced pain at the injection site. On 04-OCT-2012 the patient experienced injection site swelling, 1 day after onset of therapy and injection site redness. No treatment information was reported. The outcome of injection site swelling, pain at the injection site and injection site redness was reported as recovered/resolved. The relatedness for injection site swelling is unknown for PNEUMOVAX 23. Additional information has been requested. Additional information is not expected.
Immediately after administration of vaccines, patient had redness around the L thigh and with rash on abdomen and around neck and face. No medications administered at all.  Pt observed and immediate vitals were temp of 98, HR 105, sat of 98% and BP of 84/52. 20 minutes later, temp 96.8, Sat 98% and HR 105. Rash completely disappeared.
Information has been received from a registered nurse concerning an 8-year-old female with no pre-existing allergies, birth defects, or medical conditions who on 23-MAR-2000 was vaccinated SC in the left arm with a first dose of varicella virus vaccine live (Oka/Merck) (Lot #: "1682N" and "1588J"). There was no illness at the time of vaccination. On 17-JUL-2007, the patient was seen in the office and diagnosed with post varicella. Unspecified medical attention was sought. There were no adverse events following prior vaccination. It was noted that the patient's mother developed shingles in July 2007. There was no product quality complaint. This is one report of several from the same source. Additional information has been requested.
My husband developed a dangerous blood clot in his upper thigh,  resulting in pain and an inability to work for a few days! This was unexpected?
severe pain in left arm beginning about 3 hours later, inability to raise arm forward or laterally, pain slowly reduced, on Feb. 12 able to wash hair, Feb. 13 still sore but better, felt like it would be normal very soon.  On Feb. 8 was also tired and slept.  Also very briefly felt throat soreness and postnasal drip, but that quickly resolved.  On Feb. 14 woke up and arm pain was as severe as it had been initially.  Medicated throughout the day.  It began to slowly get better again, then on Feb. 17 woke with right arm pain.  About noon developed aches (including headache), chills, fatigue, and fever which got as high a 101.7.  Slept most of the day and night, woke feeling less achy and feverish, but low-grade fever continued throughout the day.  Got a Covid test as doctor's office thought it unlikely to be vaccine reaction, but Covid test was negative, and so I am filing this report.  Had very minor nasal congestion, which is not unusual for me, and no symptoms of illness other than aches, fever, chills, and fatigue.
syncope; POTS (autonomic dysfunction, orthostatic intolerance, fatique, dizziness, headache, syncope); autonomic dysfunction; orthostatic intolerance; fatique; dizziness; headache; This initial spontaneous report was received from a lawyer regarding a case in litigation referring to a 21-year-old female patient. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. On an unknown date, the patient was vaccinated with Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) (exact dose, lot#, expiry date, route of administration and anatomical location were not provided) for prophylaxis. On an unknown date, the patient experienced postural orthostatic tachycardia syndrome (POTS), autonomic dysfunction, orthostatic intolerance, syncope, fatigue, dizziness and headache. Reported date of injury was unspecified date in 2013. The outcome of the events was not reported. The lawyer considered all events to be related to Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL).  Upon internal review, the event of syncope was determined to be medically significant.   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2301USA006946:
it was convulsive shaking; I started shaking so bad/I was shaking out of my skin/shaking lasted for 15-20 minutes; chill bumps; I could not stand up; This spontaneous case was reported by a consumer and describes the occurrence of SEIZURE (it was convulsive shaking) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007821A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2021, the patient experienced SEIZURE (it was convulsive shaking) (seriousness criterion medically significant), TREMOR (I started shaking so bad/I was shaking out of my skin/shaking lasted for 15-20 minutes), PILOERECTION (chill bumps) and DYSSTASIA (I could not stand up). On 20-Apr-2021, SEIZURE (it was convulsive shaking), TREMOR (I started shaking so bad/I was shaking out of my skin/shaking lasted for 15-20 minutes), PILOERECTION (chill bumps) and DYSSTASIA (I could not stand up) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       It was reported that, patient was scared to take the 2nd vaccine.  Patient almost fell back.   Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Low grade fever, headache,chills,fatigue,nausea on morning of 04/02/2021.all day and evening. On morning of 04/03/2021 low grade fever,headache. As of afternoon no fever,headache ,chills or nausea. But still fatigued.
LITTLE SORE IN LEG MUSCLES; METALLIC TASTE IN MOUTH; SICK STOMACH; TIRED; This spontaneous report received from a patient concerned a patient of unspecified age and sex. 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, and batch number were not reported) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination.  Batch number was not reported has been requested No concomitant medications were reported. On 09-APR-2021, the subject experienced sick stomach. On 09-APR-2021, the subject experienced tired. On 12-APR-2021, the subject experienced metallic taste in mouth. On an unspecified date, the subject experienced little sore in leg muscles. Treatment medications (dates unspecified) included: povidone-iodine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sick stomach, tired, little sore in leg muscles and metallic taste in mouth was not reported. This report was non-serious.
13x14 cm erythema/edema left deltoid same vesicles. Tx=ice, Motrin
At 17:15, my throat started to swell and I had trouble swallowing. Then I began shaking all over, uncontrollably. I had slight trouble breathing. I went to ER around 17:45 and was give a shot of Benadryl.
itching all over included head & eyes;boils & bumps containing blood & pus;hard matter on face, neck & behind & inc between upper legs & behind;also on back & chest;began 48hr post vax;total 13 outbreaks of bumps;cont having new outbreaks
Information has been received from a physician via a field representative concerning a 74 year old male patient. on 13-AUG-2012 the patient was vaccinated with ZOSTAVAX lot # 0564AE expiration date unspecified, 1 dose/once, subcutaneously. Concomitant therapies included hydrochlorothiazide, TOTAPEN, metformin, latanoprost, aspirin (baby), fluticasone and "VATROPRALOL" (correct spelling unknown). On 12-FEB-2015 the patient developed shingles that had crossed two dermatomes. The physician also stated this case of shingles was not too painful for the patient. The patient visited the Doctor's office for medical attention. An unspecified antiviral medication was given to the patient. None lab diagnostics study was performed. The outcome of the event was reported as not recovered. The reporter did not assess the causality. Additional information has been requested.
Syncope: passed out within one minute of administration with body jerking. I help my daughter on the table. It lasted 30 seconds. She had nausea and had diarrhea and headache one hour following the shot.
Severe pain at injection site and under arm pit for over 72 hours that OTC pain relievers cannot control. Arm pits feels inflamed. Cannot rotate or lift arm fully.   Injection site warmness, Body chills and fatigue within first 24 hours.  These side effects have subsided.
As of 12/16/2017 still experiencing soreness in area where vaccine was given on 11/13/2017. Unable to raise arm over head, restricted range of motion, and constant pain daily.
Patient called me 10/20/2014 to inform that she had a hot, red lump on her injection arm about 3 inches lower than the site injection. It lasted for 3 days.
Headache, Myalgia, Pain at site, fatigue and tiredness and benigh paroxysmal positional vertigo Narrative: Symptoms lasted 12 hours and resolved without medical interventions.
1 of 3 pts vaxed devel inject site reaction which began 4-5 hrs following vax; arm was very painful, hot to the touch & erythema was approx 7" in diameter; no ATB given;
Admit for hypertensive urgency and encephalopathy in setting of COVID infection; tested + in ER. Did not require O2. Received vit-d, vit-b, singulair, zinc. Husband signed pt out.
Headache, nausea, dizziness, tense feeling and tachycardia. Heart rate increased to 149 and then ran around 120 for over 8 hours after receiving the vaccine.
This spontaneous report was received from a 80 year old male patient, reporting on herself. The patient did not have any drug reactions or allergies. No information regarding the patient's pertinent medical history or concomitant therapies was provided. In approximately 2006 (reported as about 10 years ago), the patient was vaccinated with a dose of ZOSTAVAX (lot #, expiration date, exact dose and route of administration were not reported). The patient reported that from time to time he got a rash in the back of his head (onset date was not reported). He used CORTAID cream and ointment for the event and the rash came and went. The patient did not seek any medical attention and no lab diagnostic studies were performed. The outcome of the event was unknown. The relatedness between the event and ZOSTAVAX was assessed as possible. However, the patient was not sure if the vaccine was the one that had caused the rash. Additional information is not expected as there was no consent to contact the patient's physician.
vaccine given after its expiration date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccine given after its expiration date) in a 25-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 013h21b) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Mar-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 22-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccine given after its expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (vaccine given after its expiration date) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant and treatment medication was not reported.
pt recv vax 12OCT95 & on approx 15NOV95 pt devel papulosquamous eruptions w/petechia;29NOV95 pt was evaluated by the MD & noted to have what looked like pityriasis lichenoides et varioliformis;the rash was non-pruritic w/no vasculitis;
This spontaneous report as received from a registered nurse refers to a female patient of unknown age with no allergy or drug reactions. On 29-SEP-2014 the patient was vaccinated with M-M-R II, 0.5 ml, subcutaneous (lot # and expiration date not reported). On the same date (29-SEP-2014) within 30 minutes the patient began to experience  mild throat tightness and lip tingling which resolved within 30 minutes. No treatment was given. The patient did not seek medical attention. The outcome of mild throat tightness and lip tingling was reported as recovered/resolved on 29-SEP-2014. Additional information has been requested.
no additional AEs; vaccine was administered after temperature excursion; This spontaneous report was received from a certified medical assistant and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 26-JAN-2023, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA)(PROQUAD) subcutaneous injection, 1 dose, lot #W029553, expiration date: 14-MAR-2024, administered for prophylaxis (route of administration was not provided). The vaccine was administered after temperature excursion at 6.9 degrees Fahrenheit (F) for 15 minutes (product storage error). Previous temperature excursions were at 7.1 F for 30 minutes and at 11.6 F for 1 hour. No additional adverse events (AEs) were provided.
Information has been received from a physician concerning a 57 year old female who on 13OCT2003 was vaccinated in the RA with a second dose of pneumococcal 23v polysaccharide vaccine. The first dose was 5 to 6 years ago. On 13OCT2003 the pt experienced horrible pain and swelling at the injection site RA. On 14OCT2003 the pt was in the office with chills, but no fever. She had taken ibuprofen earlier in the day. She also had myalgias, arthralgias, (joints hurting) shortness of breath and overall not feeling well. It was reported that the physician was concerned that this may be a serum sickness/ allergic response. An unknown treatment was reported for the event and the pt had not recovered. Additional information has been requested.
Diagnosed with an A-Fib; She went to pick up a glass of water, and she does not remember dropping the glass but it crashed to the floor and it broke. She does not remember anything about that; A very strange thing happened; Had a very violent reaction; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ATRIAL FIBRILLATION (Diagnosed with an A-Fib) and LOSS OF CONSCIOUSNESS (She went to pick up a glass of water, and she does not remember dropping the glass but it crashed to the floor and it broke. She does not remember anything about that) in a 75-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.     Concurrent medical conditions included Penicillin allergy and Allergy NOS (morphin).   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Feb-2021, the patient experienced ATRIAL FIBRILLATION (Diagnosed with an A-Fib) (seriousness criterion hospitalization), LOSS OF CONSCIOUSNESS (She went to pick up a glass of water, and she does not remember dropping the glass but it crashed to the floor and it broke. She does not remember anything about that) (seriousness criterion medically significant), FEELING ABNORMAL (A very strange thing happened) and VACCINATION COMPLICATION (Had a very violent reaction). At the time of the report, ATRIAL FIBRILLATION (Diagnosed with an A-Fib), LOSS OF CONSCIOUSNESS (She went to pick up a glass of water, and she does not remember dropping the glass but it crashed to the floor and it broke. She does not remember anything about that), FEELING ABNORMAL (A very strange thing happened) and VACCINATION COMPLICATION (Had a very violent reaction) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Electrocardiogram: atrial fibrillation (abnormal) Atrial fibrillation.         Concomitant medications include natural fibroid 60 mg, Biestrogen  (Hormone regulator). Treatment medication include unknown intravenous medication.  Based on the current information and temporal association between the use of the product and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on the current information and temporal association between the use of the product and the start date of the events a causal relationship cannot be excluded.
Right sided Bell's Palsy Grade IV; This is a spontaneous report from a contactable physician. A 42-Year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot Number: Unknown) intramuscular, administered in left arm on 15Mar2021 (at the age of 41-years-old) as SINGLE DOSE, dose and second dose was intramuscular, administered in left arm on 05Apr2021 as SINGLE DOSE for covid-19 immunization. Medical history included covid-19 and ongoing allergies. Concomitant medication was Benadryl PRN for allergies. On 09Apr2021,the patient experienced right sided bell's palsy grade iv. The patient underwent lab tests and procedures which included sars-cov-2 test was pending on 09Apr2021 Covid test type post vaccination done by nasal swab. Therapeutic measures were taken as a result of right sided bell's palsy grade iv included Prednisone Taper and pain medication. The outcome of event was not recovered.  Information about the Lot/batch number has been requested. ; Sender's Comments: Considering a plausible temporal relationship, a possible contributory role of suspect vaccine BNT162B2 to the reported event facial paralysis cannot be completely excluded. 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 regulatory authorities, Ethics Committees, and Investigators, as appropriate.
56 adults patients received doses after its expiration date Jul 13, 2022; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (56 adults patients received doses after its expiration date Jul 13, 2022) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 004m21a) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (56 adults patients received doses after its expiration date Jul 13, 2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (56 adults patients received doses after its expiration date Jul 13, 2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (56 adults patients received doses after its expiration date Jul 13, 2022).    No concomitant medications were reported. It was unknown whether patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. Caller mentioned that "the CDC had just approved extended expiration dates" and wanted to know if it was extended. When asked the caller stated that there were no remaining vials unused of that lot number and agent reminded the caller that no patients should receive doses from expired vials. Dose was administered after 30-day Use by Date or after manufacturer date of expiry. Vial did not undergo any temperature excursions.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-701125 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-701125:Master case (1 of 56 patient)
chills; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHILLS (chills). At the time of the report, CHILLS (chills) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant medication nor teeatment information provided.