chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a registered nurse concerning an 18 year old female with a history of migraines and no known drug allergies who on 16-NOV-2007 was vaccinated with the first dose GARDASIL 0.5 mL IM (Lot # 0469U). Concomitant therapy included YASMIN. On 16-NOV-2007 shortly after she received the first dose, the patient developed a migraine. She received the second dose on 21-JAN-2008 (Lot # 655327/1287U). On the evening of 22-JAN-2008, the patient experienced an itchy rash on both arms, legs and trunk which was spreading up her neck by the morning of 23-JAN-2008. The nurse reported that the patient had recently been sitting in a hot tub with friends for a few hours a day. The rash was not evaluated by a health care professional but was reported by the patient to the office. The nurse indicated the rash was not thought to be hives or indicative of hypersensitivity. Th rash was treated with topical BENADRYL. As of 23-JAN-2008, the patient was recovering. Additional information has been requested. This is in follow-up to report(s) previously submitted on 2/14/2008.  Initial and follow-up information has been received from a registered nurse concerning an 18 year old female with a history of migraines and no known drug allergies who on 16-NOV-2007 was vaccinated with the first dose of GARDASIL IM (Lot # 0469U).  Concomitant therapy included YASMIN.  On 16-NOV-2007 shortly after  she received the first dose, the patient developed a migraine. She received the second dose on 21-JAN-2009 (Lot # 655327/1287U).  On the evening of 22-JAN-2009, the patient experienced an itchy rash on both arms, legs and trunk which was spreading up her neck by the morning of 23-JAN-2009 and to the entire body later.  On an unspecified date the patient had headache.  The nurse reported that the patient had recently been sitting in a hot tub with friends for a few hours a day.  The patient called back later that day to admit that the rash may have been due to chemicals in the water versus the second dose of GARDASIL.  The rash was not evaluated by a health care professional but was reported by the patient to the office.  The nurse indicated the rash was not thought to be hives or indicative of hypersensitivity.  The rash was treated with topical BENADRYL.  On an unspecified date the patient had recovered.  Additional information is not expected.
swelling near the injection site; This is a spontaneous report received from contactable reporter (Pharmacist) from a sales representative. A patient (no qualifiers provided) received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13) (Batch/Lot number: unknown) as dose number unknown, single for immunization; varicella zoster vaccine rge (cho) (SHINGRIX) (Batch/Lot number: unknown) as dose number unknown, single for immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE SWELLING (non-serious), outcome "unknown", described as "swelling near the injection site".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Booster (3rd) dose given to patient under 16 years old. Last (2nd) dose given on 05/19/21. No adverse event at vaccination clinic. Spoke with mother, and informed that boosters weren't currently approved for age if not immunocompromised. Informed to make sure sign up for V-Safe and monitor as done with previous doses. Mom denied adverse reaction from other 2 doses
new onset heart failure after booster vaccine, development of autoimmune inflammatory arthritis (SLE vs RA) after initial two doses of vaccine Arthritis treated with prednisone and hydroxychloroquine Heart failure treated with standard treatment (metoprolol, secubitril, spironolactone, furosemide), recent evidence for possible myocarditis on cardiac MRI done 10/5/22 may change management
LEFT ARMPIT STARTED SWELLING; LEFT ARMPIT TURNED RED / REDNESS; RASH; This spontaneous report received from a patient concerned a 19 year old male. The patient's weight was 195 pounds, and height was 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, batch number: 1808978, and batch number: 1808978 expiry: UNKNOWN) dose was not reported, administered on 03-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced rash. On 03-APR-2021, the subject experienced left armpit started swelling. On 03-APR-2021, the subject experienced left armpit turned red / redness. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from left armpit started swelling, rash, and left armpit turned red / redness. This report was non-serious.
Large amount of edema and swelling at injection site. Also possible Cellulitis in upper arm. Doctor appoint with gp at 01 pm 3/3/2017.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. There was no information about the patient's concomitant medications, allergies and pertinent medical history reported. On 01-MAR-2017, the patient was vaccinated with an expired dose of PNEUMOVAX23 lot # L017265, expiry date: 10-FEB-2017 (dose, anatomical location and route of administration were not reported). No adverse effects were reported. Additional information has been requested.
Started as sore arm and red spot at injection site. Red rash got bigger and bigger spreading down arm to elbow. Rash itches. It has been two weeks. Started antibiotics today 1/27/21 and diphenhydramine.
doses given after temperature excursion; Product storage error; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses given after temperature excursion) and PRODUCT STORAGE ERROR (Product storage error) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039F21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses given after temperature excursion) and PRODUCT STORAGE ERROR (Product storage error). At the time of the report, EXPIRED PRODUCT ADMINISTERED (doses given after temperature excursion) and PRODUCT STORAGE ERROR (Product storage error) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medication was not provided.  Concomitant medication was not provided.
I woke up the morning of Oct. 10 feeling fine and normal. I received a flu vaccination at about 9:30 AM. By 2:30 I didn't feel well and was achy all over. I continued to feel badly until bedtime. I went to sleep by 9:00PM, but awoke at 1:30AM feeling worse. I took my temperature and it was 103.3º. I had a feeling of impending doom, and think that I may have been experiencing pre-seizure activity aura at that point, although I've never had a seizure before. I administered cooling measures to myself, including taking 1200mg Ibuprofen, a cool shower and rubbing with a damp towel. If it hadn't been in the middle of the night/early morning, I would have awakened my wife and had her take me to the emergency room. After about 2 to 3 hours of continued cooling measures, my fever broke and I was able to get to sleep. When I woke up I felt normal with no aches or fever. The injection site didn't even hurt. I'm convinced that this was a reaction to the flu vaccination I received.
Injection site red, warm, 6cm x 8cm, not tender to touch, good ROM, itchy left shoulder.
Information regarding Prevnar was received from a nurse regarding a 1-year-old male patient who received a dose of Prevnar and a dose of Ipol on an unspecified date in 2002. The child developed a fever of 104 to 105 degrees Fahrenheit that lasted a week. On an unspecified date in 2002, the patient received a dose of Prevnar  along with another childhood vaccine. After vaccine administration, the patient developed a fever of 104 to 105 degrees Fahrenheit that lasted a week. On an unspecified date, the patient recovered from the event with treatment (not specified). Body temperature (results: 104 to 105 degrees Fahrenheit) was done. No additional information was available at the time of this report.
Tissue loss; Muscles more defined on the left arm; Tenderness on the left arm; Injection site is itchy; This spontaneous case was reported by a consumer and describes the occurrence of TISSUE INJURY (Tissue loss), VACCINATION SITE PRURITUS (Injection site is itchy), MYALGIA (Muscles more defined on the left arm) and VACCINATION SITE PAIN (Tenderness on the left arm) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, the patient experienced VACCINATION SITE PAIN (Tenderness on the left arm). In March 2021, the patient experienced VACCINATION SITE PRURITUS (Injection site is itchy). On an unknown date, the patient experienced TISSUE INJURY (Tissue loss) and MYALGIA (Muscles more defined on the left arm). In March 2021, VACCINATION SITE PAIN (Tenderness on the left arm) had resolved. At the time of the report, TISSUE INJURY (Tissue loss), VACCINATION SITE PRURITUS (Injection site is itchy) and MYALGIA (Muscles more defined on the left arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided. Treatment information was not provided.
pt recv vax & devel an inj site rxn characterized by an 8cm by 8cm area of redness, swelling & warmth;rxn was described as cellulitis;pt self treated w/application of ice & recovered w/in 5 days;
Waited 5 months to get the second; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Waited 5 months to get the second) in a patient of an unknown age and gender 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Waited 5 months to get the second). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Waited 5 months to get the second) had resolved.            No concomitant medications were not reported.  No treatment medications were not provided.
Injection was made into my shoulder capsule, not my arm. The injection itself was very painful. For 2.5 hours, I had no further pain. At approximately 2.5 hours after the injection, I experienced severe pain in my shoulder and upper arm. Now 3 days later, I have limited arm movement and continuing pain. My orthopedist believes that the injection was made directly into the rotator cuff. Treatment will entail anti-inflammatories, which I am not generally supposed to take because of CKD, physical therapy, and 6-8 weeks if I?m lucky.
Fever as high as 101, low grade of 99.4-100.6 most of the time, started the morning after the injection. Full blown allergy attack with sneezing and runny eyes, even though I take allergy medicine regularly. An overall unwell feeling and tiredness, muscle soreness, arm is moderately sore. I am on day 4 now and a large sore red spot is about 2 inches below the injection.
experiencing nausea /   I felt kind of nauseous, and it was still there this morning; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (experiencing nausea /   I felt kind of nauseous, and it was still there this morning) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B2A) for COVID-19 vaccination.     No medical history was provided by reporter.  No concomitant medication reported.     On 17-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-May-2021, the patient experienced NAUSEA (experiencing nausea /   I felt kind of nauseous, and it was still there this morning). At the time of the report, NAUSEA (experiencing nausea /   I felt kind of nauseous, and it was still there this morning) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medications were provided.
Pain and swelling left lower leg. US  shows blood clots left thigh. Put on a blood thinner. Pain and swelling currently continues. Will be on blood thinner for at least 6 months.
Systemic: Body Aches Generalized-Medium, Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Chills-Mild, Systemic: Fever-Mild, Systemic: moderate arm soreness-Mild
Been sick as a dog for 5 days.  Can't stop vomiting, horrible headache, fatigue, lost 7 pounds, arm inflamed, badly swollen
Nausea, vomiting, diarrhea, headache, shortness of breath, dizziness, extreme tiredness
I had some "brain fog" throughout the afternoon of not remembering where I put things or what I was doing moments before I questioned what was going on. Temporary memory loss of events happened for at less than 30 minutes. I remember going to the bedroom with my fiance and us talking about the possibility of being intimate. I thought we just went to bed and I woke up at 5:30am naked. I questioned my fiance about why I was not dressed. He told me we did get intimate and I seemed myself except saying things I would never normally say. He thought I was role playing. I do not remember any of those events and it was very scary. I have not had any further issues that I am aware.
The patient has arm pain and limited range of motion for couple of weeks after vaccination.  Pharmacist didn't see any redness or bruise near vaccination site.
HCP calling to report accidental vaccination of RECOMBIVAX in combination with VAXELIS for 6 month old male patient. No additional AE; This non-serious spontaneous safety report, with MSD case number 02437630 (Interaction number 02437615), was received by partner on 27-JUL-2023 and forwarded to company on 28-JUL-2023 from a health care professional.  The causal relationship between Vaxelis and the reported event "HCP calling to report accidental vaccination of RECOMBIVAX in combination with VAXELIS for 6 month old male patient. No additional AE" was assessed as not applicable due to the nature of the event.  Further information is expected.
Patient received DTaP and IPV to left upper leg 07/17/2003-am of 07/18/2003.  Area to left upper leg warm to touch and hard.  Erythemous area 3.5in x 2.5 in.  No drainange noted from injection site.
For 7 days after the vaccine, blood in the stool (dark black) and several nose bleeds.
Beginning that night, severe night sweats. I have had hormones monitored and regulated since 2011. Had zero night sweats since 2012. Since 9/3/2021 hormones have been messed up which triggered severe night sweats and hot flashes every 1.5 hours. Every night and day, constantly.
Shingrix diluent administered alone; Shingrix diluent administered alone; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) (batch number FCEFF, expiry date 23rd September 2023) for prophylaxis.   In July 2022, the patient received Shingrix. In July 2022, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 26-Jul-2022 Reporter's Comments:  Office Administrative knew that from 18th July to 25th July 2022, an unknown patient received Shingrix diluent portion alone without the powder. The reporter gave consent to follow up. Additional supportive Information: The patient received Shingrix diluent portion alone without the powder which led to inappropriate preparation of medication and inappropriate dose of vaccine administered
coughing; runny nose; coughing; chemical taste and smell after injection; chemical taste and smell after injection; chills; fatigue; rash around injection site; This spontaneous case was reported by a consumer and describes the occurrence of the first episode of COUGH (coughing), RHINORRHOEA (runny nose), the second episode of COUGH (coughing), DYSGEUSIA (chemical taste and smell after injection) and PAROSMIA (chemical taste and smell after injection) in a 65-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.     No Medical History information was reported.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced the first episode of COUGH (coughing), RHINORRHOEA (runny nose), the second episode of COUGH (coughing), DYSGEUSIA (chemical taste and smell after injection), PAROSMIA (chemical taste and smell after injection), CHILLS (chills), FATIGUE (fatigue) and VACCINATION SITE RASH (rash around injection site). At the time of the report, RHINORRHOEA (runny nose), the last episode of COUGH (coughing), DYSGEUSIA (chemical taste and smell after injection), PAROSMIA (chemical taste and smell after injection), CHILLS (chills), FATIGUE (fatigue) and VACCINATION SITE RASH (rash around injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication details was reported. No treatment medication details was reported.
Onset of fever treated with infant TYLENOL PRN. Localized red area size of quarter, warm to touch away from injection site. (ACT-HIB).
Red rash formed on left neck within 14 hours.  Rash worsened day-by-day to where it infected all body parts, especially the face and neck.  Intense itching and redness.  Shortness of breath on day 7 and 8.   On day four, prescribed two Zyrtec a day and Triamcinolon.  On day seven, prescribed Prednisone.  On day nine, prescribed Hydroxyl, Epineprine 0.3 MG/INJ AMNE, and Aug Betamet 0.05% Oin Foung
Patient received the incorrect Pfizer vaccine concentration.  Patient received 12+ rather than 5-11. No untoward events.
I had a fever of 104 and had to use Tylenol to relieve the fever. Then I started to have hives all over my body, took Zyrtec from the doctor but the hives still have not gone away. The fever comes and goes, and I am coughing with nasal congestion.  The hives stopped when I had a fever but came back as soon as the fever goes away. The Zyrtec helps and they go away but when I don't take it, they come right back.
Patient received 1st covid vaccine on 2/16/21 and the 2nd dose on 3/16/21. Patient presented to outside hospital on 10/6/21 with worsening cough, SOB and chest pressure that started since July 2021 found to have large L pleural effusion and moderate pericardial effusion. She had signs of systemic inflammation with a leukocytosis to 17.6, D-dimer of 2500, ESR of 101, and CRP of 250. Patient was covid negative. Chest x ray demonstrated a left sided moderate pleural effusion with retrocardiac opacity and moderate pulmonary interstitial edema. EKG re demonstrated the moderate circumferential pericardial effusion with consolidated appearance and no evidence of tamponade. Patient received cardiac mri on 12/10/21 as an outpatient and below is the conclusion. 1.  There is mild thickening and late gadolinium enhancement of the pericardium, likely representing ongoing pericardial inflammation. No pericardial edema to indicate acute pericarditis. Interval resolution of pericardial effusion. No evidence of pericardial constriction. 2.  Conglomerate of lymph nodes in the right anterior mediastinum which is decreased in size slightly compared with prior imaging may be reactive. This can be reassessed with contrast enhanced CT chest in 2-3 months. 3.  Small left pleural effusion with interval decrease in size.
Vertigo; nausea; Thinks had a low grade fever; developed fever rash on chest and a bit on face.; This is a spontaneous report from a contactable consumer. A 49-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number and expiry date not reported), via an unspecified route of administration, on 09Feb2021 (at the age of 49-year-old), as dose 2, single, for COVID-19 immunisation. Patient was not pregnant at the time of vaccination. The patient medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number and expiry date not reported), via an unspecified route of administration, on an unspecified date in Jan2021 (at the age of 49-year-old), as dose 1, single, for COVID-19 immunisation. It was unknown if patient received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. It was unknown if patient had been tested for COVID-19 since the vaccination. The patient experienced vertigo, nausea, a low grade fever and fever rash on chest and a bit on face on 10Feb2021. Patient received no treatment for the events. The outcome for all the events was recovered on an unspecified date.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Continued pain in left shoulder beyond 48 hours - limited range of motion.  Shooting "pins and needles" pain down left arm.  Constant numbness in thumb, index and middle fingers of left hand.  Muscle spasms under armpit of left arm.
Pregnancy confirmed on 8/9/21. EDD 4/18/22.  Spotting and cramping were noted on 8/17/21. A sonogram on 8/20/21 visualized subchorionic hemorrhage and fetal pole. Sonogram on 8/30/21 - no hemorrhage noted. Normal pregnancy and gestational age were noted. Fetal pole and heartbeat observed. A sonogram on 9/7/21 noted the arrest of gestational growth and absence of heartbeat.  Spotting and cramping were noted from 8/17/21 through 8/30/21. Arrest to fetal growth estimated at 9/1/21.  History of prior miscarriage x 5. History of live term birth x 1.
Developed cold symptoms a few days ago. Should I get the booster if I have cold symptoms; This spontaneous case was reported by a nurse and describes the occurrence of NASOPHARYNGITIS (Developed cold symptoms a few days ago. Should I get the booster if I have cold symptoms) in a  patient of an unknown age and gender 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced NASOPHARYNGITIS (Developed cold symptoms a few days ago. Should I get the booster if I have cold symptoms). At the time of the report, NASOPHARYNGITIS (Developed cold symptoms a few days ago. Should I get the booster if I have cold symptoms) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided. Treatment information was not provided.