chrisvoncsefalvay/vaers-outcomes huggingface dataset:
soreness; achiness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soreness) and PAIN (achiness) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included CITALOPRAM, HYDROCHLOROTHIAZIDE and SIMVASTATIN for an unknown indication.   On 24-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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 05-Nov-2021, the patient experienced PAIN IN EXTREMITY (soreness) and PAIN (achiness). On 06-Nov-2021, PAIN IN EXTREMITY (soreness) and PAIN (achiness) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medication details was reported.   This case was linked to MOD-2021-419686, MOD-2021-419744 (Patient Link).
Received Measles vaccine that AM. Was in he ER that evening with an intussception.
Information has been received from a nurse practitioner concerning a 12 month old female twin who was vaccinated on an unspecified date with a 0.5ml dose of measles virus vaccine live  (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (+) varicella Virus Vaccine live (upgrade process). On 5/10/2006, the patient developed a measles like rash. Unspecified medical attention was sought. No outcome was reported. No product quality complaint was involved. The reporter indicated that the patients twin sister experienced an adverse event following vaccination WAES0606USA00914. Additional information has been requested.
Called to see pt as rapid repsonse appx 1 hour after receiving first Moderna vaccine. Pt endorsed dizziness, generalized weakness, dyspnea at rest, generalized CP. Pt reported sx felt like previous asthma attacks. No anginal equivalents, other respiratory s/sx. No localizing neurologic c/o. Reports SMBG at home recently "all lower than 200". BG level of pt was 302. Upon entering exam room pt noted to be pale with pulse in 110s. No increased effort of breathing, oximetry high 90s on RA, BP wnl. Exam per above. EKG performed after all vitals and glucose obtained and was normal. Checked VS every 5 minutes x 2 with decrease of HR to normal range. Pt subjectively felt better at this time, had regained normal color, and 15 minutes later requested going home.
Urticaria, both arms and legs. Treated with antihistamines and topical aloe
After the 3rd dose of oral typhoid vaccine, client reported severe diarhea, nausea and dizziness when standing. Stated had become progressively worse with each subsequent dose.
2 hours after vaccination noticed 2 hives on LLE, 4 hours after vaccination symptoms exacerbated to severe headache, ear pain, swollen facial features, periorbital edema, jaw pain, esophageal tightening, sternal tightening, SOB, PVC's, tachycardia; symptoms lasting for 1 1/2 hours. Symptoms subsided for 30 minutes, next round of same symptoms as above recurred for another 30 minutes. Took 325mg aspirin after 2nd round of symptoms. Notified Dr. 9/10/2015 at approximately 0800. Pt did not seek medical treatment.
Heart fluttering; Metallic Taste almost immediately after vaccine; Numb tongue + lips; Headache; Fever; Loss of memory; Brain Fog; This is a spontaneous report from a contactable other Health Care Professional (patient). A 20-years-old non-pregnant female patient received first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: Solution for injection, Batch/Lot Number and Expiration date was unspecified), intramuscularly, administered in the left arm on 20Aug2021 at 16:15 (at the age of 20-years-old) as dose 1, single for COVID-19 immunization at public health clinic or veterans administration facility. Medical history included endometriosis from an unknown date, and Patient had known allergies to Carrots, Dust Mites, codeine. Concomitant medication within 2 weeks of vaccination included cetirizine hydrochloride (ZYRTEC DAIICHI) taken for an unspecified indication, from an unknown start date. Prior to vaccination, the patient was not diagnosed with COVID-19 and did not receive any other vaccines within 4 weeks. Since the vaccination, the patient has not been tested for COVID-19. On 20Aug2021 at 17:00, patient developed metallic taste (almost immediately after vaccine) and also experienced heart fluttering, numbness in tongue and lips, headache, fever, loss of memory and brain fog. The events resulted in healthcare professional office or clinic visit. The patient not received any treatment for the events. The outcome of the events was reported as not recovered at the time of report.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Based on the close temporal association the possibility of causal association between the event heart fluttering  and the suspect drug BNT162B2 cannot be ruled out. 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
left arm was; diarrhea; chills for a few dayschills for a few days; extremely fatigued to where she stayed in bed; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (left arm was ), DIARRHOEA (diarrhea), CHILLS (chills for a few dayschills for a few days) and FATIGUE (extremely fatigued to where she stayed in bed) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID] for Product used for unknown indication, BENAZEPRIL, VITAMIN D;VITAMIN E, SIMVASTATIN and VITAMIN C [ASCORBIC ACID] 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 an unknown date, the patient experienced PAIN IN EXTREMITY (left arm was ), DIARRHOEA (diarrhea), CHILLS (chills for a few dayschills for a few days) and FATIGUE (extremely fatigued to where she stayed in bed). At the time of the report, PAIN IN EXTREMITY (left arm was ) had resolved and DIARRHOEA (diarrhea), CHILLS (chills for a few dayschills for a few days) and FATIGUE (extremely fatigued to where she stayed in bed) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Other concomitant medication included gartriptalin Treatment information included use ice packs on arm when needed.   This case was linked to MOD-2021-119093 (Patient Link).
started hurting same day of shot. i cried. i cant lift my arm at all. i cant dress or bath or anything. my shoulder is swollen.  I can only lift it with my other arm. pain goes up my shoulder to the back of my neck and up my head. The shot was given in the muscle and  joint. It was am immediate pain.
got shingles vaccine and died four months later; This case was reported by a consumer via interactive digital media and described the occurrence of death in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 4 months after receiving Shingles vaccine, the patient experienced death (serious criteria death and GSK medically significant). On an unknown date, the outcome of the death was fatal. The reported cause of death was unknown cause of death.   It was unknown if the reporter considered the death to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the patient's friend. The age at vaccination was not reported. The reporter stated that, the patient got shingles vaccine and died four months later. The follow-up would not possible as no contact details were available.; Reported Cause(s) of Death: Unknown cause of death
Narrative:  COVID infection following COVID vaccine series 03/22 COVID vaccine dose #1 04/12 COVID vaccine dose #2 12/14 pt c/o congestion, wheezing, coughing up clear mucus, no fever, reports COVID test was negative, requested meds for symptoms; prescribed albuterol, benzonatate, mucinex 12/15 pt c/o cough, headache, rhinorrhea x 1 week; COVID positive 12/16 pt reports cough improving, sinus headache resolved, no SOB but wheezing 12/17 pt reports feeling better, declines further check in calls
Case number PHEH2013US008712, is an initial spontaneous report received from a nurse on 16 Apr 2013 with a follow up information received on 13 May 2013: This case refers to a female patient of unspecified age. She received only the Men A component of MENVEO (batch number: not reported), reconstituted with sterile water intramuscularly on 09 Apr 2013. Reporter stated that, since there was an extra MenCYW-135 liquid conjugate vaccine component of MENVEO vial in the package and all the powder vials were gone. Reporter also stated that, they documented a sterile water lot number for MENVEO administration for this patient. The nurse stated that she called to ask about a possibly compromised dose, however through a more thorough investigation, the powder vial was recovered. The powder vial was recovered. The powder vial was placed incorrectly in a different box. No adverse reaction was reported following this administration error. Follow up information received on 13 May 2013: Reporter comment updated.
pt recv vax 18JUL95 & 15NOV96 pt devel 50 chickenpox lesions all over body;presented to MD;MD felt that pt may have exp vaccine failure;
Tinnitus began about 36 hours after the vaccine. Became unbearable for the next couple of weeks. I have stepped up my allergy medications and over time, i.e. 2.5 months, the tinnitus has gradually decreased/
A dose was administered to a patient from a vial that was expired/ The vial was kept in refrigerator for 31 and a half days before administering; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 28-Sep-2021 and was forwarded to Moderna on 28-Sep-2021.    Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (A dose was administered to a patient from a vial that was expired/ The vial was kept in refrigerator for 31 and a half days before administering) 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 24-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (A dose was administered to a patient from a vial that was expired/ The vial was kept in refrigerator for 31 and a half days before administering). On 24-Sep-2021, EXPIRED PRODUCT ADMINISTERED (A dose was administered to a patient from a vial that was expired/ The vial was kept in refrigerator for 31 and a half days before administering) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment medications were reported.
Client presented to ECC vaccination site to receive Janssen Booster.  Client informed RN that when she received Pfizer series dose 1 on 12/30/20 and Pfizer dose 2 1/18/21, Client states she developed hives all over the body and fever the same night of both doses 5-6 hrs. after the vaccine. Client denies having shortness of breath, and no itching. Client took Tylenol for symptoms. Client states she didn?t seek emergency care. Client?s primary care provider Dr informed her it was a normal reaction and was ok for her to receive Pfizer booster. Client has no known allergies and no medical conditions. It?s never happened with other vaccines. She?s here to get Janssen, although Dr didn?t recommend Janssen, but recommended Pfizer. Client is afraid of getting Pfizer again. RN submitted a medical consult. MD approved for client to receive Janssen booster. Client was vaccinated with Janssen booster lot#1855191 by RN. Client was educated on Emergency precautions and signs and symptoms of blood clots. Client waited in observation area for 30 minutes, no symptoms were reported. Client left vaccination site in a steady gait.
Donor states that he noticed that he had a rapid heart beat after receiving the vaccination as well as labored breathing.  Donor states that it lasted for a couple of hours.  Approx 2 hours.  Symptoms started after donor got home.  Donor did not return to center until 09-05-08 and that is when he reported his reaction.
FELT FAINT; FELT UNSTABLE FOR A LITTLE WHILE; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included: allergy nos. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced felt faint, and felt unstable for a little while. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt faint, and felt unstable for a little while. This report was non-serious. This case, involving the same patient is linked to 20230129385. This case, from the same reporter is linked to 20230128189.
Rash on body; bleeding gums; loss of taste buds; swollen and cracked lips; swollen and cracked lips; inflamed anus; blistered penis; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old male patient received BNT162b2 (BNT162B2), on 31Mar2021 at 12:00 as dose 2, single (Batch/Lot number: unknown) at the age of 60 years for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Egg whites" (unspecified if ongoing), notes: Known allergies: Egg whites. The patient's concomitant medications were not reported. Past drug history included: Meloxicam, reaction(s): "Severe allergic reaction to anti-inflammatory drugs", notes: Severe allergic reaction to anti-inflammatory drugs , that I had taken on previous occasions. Meloxicam; Methylprednisolone, reaction(s): "Severe allergic reaction", notes: Severe allergic reaction to anti-inflammatory drugs , that I had taken on previous occasions. Meloxicam , and methylprednisolone. Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: Unknown. Misplaced/discarded, Vaccine Administration Time: 12:00 PM), administration date: 03Mar2021, when the patient was 60-year-old, for Covid-19 Immunization. The following information was reported: RASH (medically significant) with onset 06Oct2021 at 12:00, outcome "recovered", described as "Rash on body"; GINGIVAL BLEEDING (medically significant) with onset 06Oct2021 at 12:00, outcome "recovered", described as "bleeding gums"; PENILE BLISTER (medically significant) with onset 06Oct2021 at 12:00, outcome "recovered", described as "blistered penis"; ANAL INFLAMMATION (medically significant) with onset 06Oct2021 at 12:00, outcome "recovered", described as "inflamed anus"; AGEUSIA (medically significant) with onset 06Oct2021 at 12:00, outcome "recovered", described as "loss of taste buds"; LIP SWELLING (medically significant), CHAPPED LIPS (medically significant) all with onset 06Oct2021 at 12:00, outcome "recovered" and all described as "swollen and cracked lips". The events "rash on body", "bleeding gums", "loss of taste buds", "swollen and cracked lips", "inflamed anus" and "blistered penis" required physician office visit. Therapeutic measures were not taken as a result of rash, gingival bleeding, ageusia, lip swelling, chapped lips, anal inflammation, penile blister.  Clinical Information: Severe allergic reaction to anti-inflammatory drugs that I had taken on previous occasions. Meloxicam and methylprednisolone. Rash on body, bleeding gums, loss of taste buds, swollen and cracked lips, inflamed anus and blistered penis. No prior covid vaccination. No covid tested post vaccination.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Itching within the first hour.  Redness developed 2 hours after vaccination.  Swelling developed 2.5 hours after vaccination. Redness and swelling continue to worsen throughout the day. Itching continues. We drew a line around the redness so we can continue tracking this until she is 48 hours post-injection.
Red rash under bicep of left arm and into the armpit area and down side towards left breast. Tenderness to touch. Swollen lymph nodes in the armpit area of left arm. Day after injection patient stated she could not lift/raise her left arm. Patient started taking over the counter ibuprofen to reduce pain and swelling.
Each dose of mRNA vaccine I have received has been followed by a flair up in my eczema. This most recent bivalent booster has resulted in my worst eczema breakout yet. I also have a raised ichy spot at the injection site since receiving this most recent dose on 9/14/22
Chills, muscle cramps mainly in legs, and headache the night of. The next day, extreme fatigue and throbbing headache. Lingering headache still present on fifth day.
Information has been received from a medical assistant and refers to an unknown number of unspecified patients of unknown age and gender. The patients' concomitant medication, pertinent medical history and drug reactions or allergies were not reported. In approximately 2016, reported as on unknown dates starting on or after 11-JUL-2016, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB lot # L045117, expiration date: 06-OCT-2018 (dose and route of administration were not reported). Administered doses of vaccine experienced temperature excursion of 48 degree Fahrenheit for 30 minutes. There was no previous temperature excursion. No adverse effects were reported. Data logger was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Approx. 5 min. after vaccination client blew his car horn.  EMS responded.  Client cool, clammy, pale, stated that he felt that he was passing out.   Vital signs checked B/P 90/40, P 50, EMS provided care, emotional support.  Vital signs rechecked B/P 100/60, client reported that he felt "better but foggy."  EMS provided Gatorade.  Monitored for an additional 15 min.  Reported that he felt better.  Declined further observation or transport to ER.  Encouraged to follow up with PCP or emergency room if needed.  Verbalized understanding.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Shakiness-Mild, Additional Details: patient had vasovagal episode @ 3 minutes after receiving Janssen vaccine.  Has a history of vasovagal with blood draw and injection.
This spontaneous report was received from a nurse refers to more than 30 patients (exact number unspecified) of unknown age and gender. The patients were an unspecified mixture of both males and females. No females were pregnant. No concurrent condition or medical history was reported. On an unknown date, within the last 1-2 year, the patients were vaccinated with GARDASIL, (intramuscular, dose not provided). No concomitant therapy was reported. The patients complained about stinging at the site of injection immediately after vaccination. The stinging only lasted for a few seconds and the patients recovered. No treatment was given for the events. No product quality issue was involved. This is one of the two reports from same reporter link (1507USA005819). Additional information has been requested.
This spontaneous report was received from a registered pharmacist concerning a patient of unknown age and gender. On 02-JUL-2013, the patient was vaccinated with a dose of PEDVAX (lot number reported as H0257D, expiry date, dose and route unspecified) which was improperly stored at temperatures below 32 degrees Fahrenheit (F). No concomitant therapy was reported. No adverse effects were reported. This is one of the several reports from the same source. Additional information has been requested.
8 days after administration, patient suffered extreme stomach pain. Upon presentation to the ER, it was determined he had appendicitis. An emergency appendectomy was performed.
TACHYCARDIA; FEVER; CHILLS; BODY ACHES; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: UNKNOWN expiry: UNKNOWN) .5 ml, administered on 05-MAR-2021 to Left Arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 05-MAR-2021, the subject experienced fever. On 05-MAR-2021, the subject experienced chills. On 05-MAR-2021, the subject experienced body aches. On 06-MAR-2021, the subject experienced tachycardia. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever, chills, and body aches on 06-MAR-2021, and the outcome of tachycardia was not reported. This report was non-serious.
diarrhea; 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 DIARRHOEA (diarrhea) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (diarrhea). At the time of the report, DIARRHOEA (diarrhea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were provided  Treatment medication was not provided
Pt started COVID Vaccine series with Moderna on 6/15/22.  Pt never went and received a second Moderna dose.  When pt was in the office for a physical, we gave a Pfizer dose as the second dose.