chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case was reported by a consumer and describes the occurrence of RASH PAPULAR (Generalized Raised Rash), PRURITUS (Itching), ERYTHEMA (Redness on the skin started on the head and spread all over the body), OEDEMA PERIPHERAL (Edema on both legs) and ASTHMA (Asthma after booster) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039F21A, 028C20A and 025J2019) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Aortic valve replacement in 1993 and Pacemaker insertion (cardiac) in 2016. Concurrent medical conditions included Dust allergy and Pollen allergy. Concomitant products included ALOPURINOL, LOSARTAN, WARFARIN, LEVOCETIRIZINE and GLIPIZIDE for an unknown indication. On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 08-Nov-2021, the patient experienced RASH PAPULAR (Generalized Raised Rash), PRURITUS (Itching), ERYTHEMA (Redness on the skin started on the head and spread all over the body), OEDEMA PERIPHERAL (Edema on both legs), ASTHMA (Asthma after booster) and RASH (Generalized Raised Rash). At the time of the report, RASH PAPULAR (Generalized Raised Rash), PRURITUS (Itching), ERYTHEMA (Redness on the skin started on the head and spread all over the body), OEDEMA PERIPHERAL (Edema on both legs), ASTHMA (Asthma after booster) and RASH (Generalized Raised Rash) outcome was unknown. No concomitant medication information was provided. Patient received half dose of booster shot. Patient visited the dermatologist and was prescribed with expensive topical ointments and asthma medications. The reporter stated that they can not afford the copays and the deductibles. Reporter asked whether there were lot of reactions to Booster shot and also what they should do with the next shot and asked whether patient should receive a different COVID-19 vaccine. This case was linked to MOD-2022-539502 (Patient Link).
The day after vaccine administered pt had diarrhea for 1.5 days, fever, area of (L) arm was swollen, hot to touch, red, itchy. Date of vaccine was 11/23/10.
About 24 hours after vaccine noted fever and pain swelling at site. Continued to have fever which was relieved with Advil. Next 48 hours significant muscle aching at site along with joint aching and fever. As long as he tra
Soreness at the injection site from the onset. Developed a sore throat around 10am on 12/14. Began feeling faint around 4:30 pm on 12/14. Began experiencing fever and chills around 8:00 pm on 12/14. Began experiencing mild back cramps around 9:30 pm on 12/14.
mild numbness of teeth and tongue; mild numbness of teeth and tongue; heaviness of head; I was very tired; arm pain lasted 2 days; This is a spontaneous report from a contactable Other HCP. This Other HCP reported himself that the  58-year-old male patient received second dose of bnt162b2 (COVID 19, Pfizer), via Intramuscular on 11Jan2021 10:00 AM on Left arm at single dose for covid-19 immunisation. Medical history included history of mitral valve repair and pacemaker. Known allergies was not known. Concomitant medications included  Metoprolol 25 mg, Baby aspirin 81 mg, Antihistamine( Certizine hidrocloride 10mg,Costco brand). The patient previously took first dose of bnt162b2 (COVID 19, Pfizer), via Intramuscular on 21Dec2020 10:00 AM on Left arm at single dose for covid-19 immunisation. No other vaccine in four weeks. Side effect occurred after his 2nd dose (11Jan2021) he was feeling mild numbness of teeth and tongue heaviness of head after 30 minutes of vaccine. It lasted 5-6 hours, also he was very tired, and arm pain lasted 2 days. The events started from 11Jan2021 10:00 AM. The outcome of the events feeling mild numbness of teeth and tongue, heaviness of head was recovered on 11Jan2021. The outcome of the other event was recovered in Jan2021. No Covid prior vaccination. Covid tested post vaccination. covid test post vaccination included Rapid test on 09Jan2021 with covid test result: Negative.   Information on the lot/batch number has been requested.
Breakthrough case admission after 3 vaccines Moderna 3/24/21 Lot# 040A21A;  Moderna 4/1/21 Lot# 026B21A;  Moderna 11/7/21 Lot# 939905
Itchy; Burns; RASH; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itchy), THERMAL BURN (Burns) and RASH (RASH) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Jan-2021, the patient experienced PRURITUS (Itchy), THERMAL BURN (Burns) and RASH (RASH). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, PRURITUS (Itchy), THERMAL BURN (Burns) and RASH (RASH) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.
Sore left arm after the third full dose; Tired after the third full dose; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore left arm after the third full dose) and FATIGUE (Tired after the third full dose) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939904, 002B21A and 01120A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.   On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In October 2021, the patient experienced PAIN IN EXTREMITY (Sore left arm after the third full dose) and FATIGUE (Tired after the third full dose). At the time of the report, PAIN IN EXTREMITY (Sore left arm after the third full dose) and FATIGUE (Tired after the third full dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication were provided. No treatment medication were provided.   This case was linked to MOD-2021-379340 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 08-Nov-2021: No new information.
Patient has red, warm, aching area on the right upper arm since 10/16, which measures 7" x 8". The patient had a temp. Area of redness is increasing. The patient will take Benadryl, apply ice, and start antibiotic if area gets larger. There is no temperature today.
SICK AS A DOG; BAD CRAMPS IN STOMACH; CONSTIPATION; THROWING UP; This spontaneous report received from a patient concerned a 71 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: No pre-existing health conditions. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 30-SEP-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 28-OCT-2021, the patient experienced sick as a dog. On 28-OCT-2021, the patient experienced bad cramps in stomach. On 28-OCT-2021, the patient experienced constipation. On 28-OCT-2021, the patient experienced throwing up. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sick as a dog, bad cramps in stomach, constipation, and throwing up on 29-OCT-2021. This report was non-serious.
Headache, Myalgia, Arthralgia, NauseaVomiting, arm soreness, fatigue Narrative: States she began to experience her side effects yesterday evening after her immunization, felt fatigued, began to have a headache, took Tylenol, and this morning experiencing quite a bit of arm soreness.
So I am mostly getting all of the effects of the vaccine in my joints. I am in the medical field and cannot perform my day to day activities due to joint pain in my knuckles ( squeezing anesthesia bags, filling syringes etc. ) In addition joint pain in my knuckles has increased dramatically over the last three weeks. I have tried acupuncture therapy and hand massages which have not provided any relief.
Imun given Thursday - 6/18/09 approx. 9:30 AM. Mother reports Friday 6/19/09 AM - had increase temp of 100.8 - never went higher then that - gave OTC med's. At approx. 6:45 pm. 6/19/09 - child had a seizure. Was taken to hospital ER. At that time hospital did a work-up. Mother reports did blood work-up and a spinal tap. Was transferred to hosp ICU at approx. 3:00 AM Sat. 6/20/09. Was discharged from ICU at approx. 1:00 pm Sat. 6/20/09. Dx with Pertussis allergic reaction. Admitted to hosp with extreme agitation and vomiting on 06/22/09. Discharged 6/23/09 with Dx: Dehydration. Mother reported that with 1st and 2nd set of Imun's within 2 weeks child had issues with Resp. illness -was eval. per PMD and that neither one was Imun related.  7/15/09 MR received for DOS 6/20/09 with D/C DX:  Possible seizure 2' to DPT. Pt presented after episode of eye deviation and vomiting with low grade fever (100.8'F) and irritability. Admitted for observation with no further episodes.  7/21/09 MR received for DOS 6/23-23/09 with D/C DX: mild isonatremic dehydration, treated, resolved.  Acute gastroenteriitis. Fussiness due to same, resolved.  Pt presented with 2 day hx of vomiting, diarrhea, decreased urine output and activity and inconsolability.  Lethargic and fatigued-looking on PE. Improved with IVF.  ICD9: 276.51, 558.9, 530.81
Pain, swelling, and redness noted 1 day after vaccination.  Cold compress:  Tylenol, elevate arm.
Myalgia & Fever Narrative: Employee has reported a low-grade fever, muscle and body aches, chills, flu-like symptoms. Informed employee if symptoms get worse call 911 or go to the nearest Emergency Room. Will continue to monitor employee daily.
Sharp pain at the arm that she got shot at. Started 1 day after she has received the shot; pain has been constant since. Saw Dr approximately 2 months ago; got ibuprofen 600mg & steroids (?), ibuprofen did not work, steroids worked but pain return after discontinuation of therapy. Pt has not seen MD since, as she has no insurance.
headache; nausea; real fatigue; Chills; symptoms are worse and she had to stay in bed all day; Sick; This spontaneous case was reported by a patient and describes the occurrence of MOBILITY DECREASED (symptoms are worse and she had to stay in bed all day), ILLNESS (Sick), HEADACHE (headache), NAUSEA (nausea) and FATIGUE (real fatigue) in a 63-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 25-Oct-2022, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In October 2022, the patient experienced ILLNESS (Sick). On 25-Oct-2022, the patient experienced MOBILITY DECREASED (symptoms are worse and she had to stay in bed all day), HEADACHE (headache), NAUSEA (nausea), FATIGUE (real fatigue) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, MOBILITY DECREASED (symptoms are worse and she had to stay in bed all day) outcome was unknown and ILLNESS (Sick), HEADACHE (headache), NAUSEA (nausea), FATIGUE (real fatigue) and CHILLS (Chills) had not resolved.            No concomitant medications were reported.  On Mar-2021, the patient had received the 1st dose of Moderna COVID-19 vaccine by intramuscular route. (batch number: unknown). On Jun-2021, the patient had received the 2nd dose of Moderna COVID-19 vaccine (batch number: unknown). was taking Tylenol, Aspirin and another medication   This case was linked to MOD-2022-664670, MOD-2022-664687 (Patient Link).
Soreness at upper arm; Soreness around injection site; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Soreness at upper arm) and VACCINATION SITE PAIN (Soreness around injection site) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Soreness at upper arm) and VACCINATION SITE PAIN (Soreness around injection site). At the time of the report, PAIN IN EXTREMITY (Soreness at upper arm) and VACCINATION SITE PAIN (Soreness around injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided. Treatment details were not provided.
Sore arm, headache.  Worst side effect and most disabling was dizziness that lasted approximately 2 weeks.
no notable previous history who presented 5/1/2021 ~0130 with chest pain and shortness of breath. History notable for Moderna COVID-19 vaccination 4 days prior (that would be 4/27/21) with subsequent development of fever, myalgias, sore throat. Then on 4/30/21 developed acute onset of shortness of breath and chest pain. Seen at ED. Exam and work-up revealed elevated troponin, unremarkable CTA of chest, EKG with diffuse slight ST changes. Patient was subsequently admitted to hospital for possible myocarditis. Per consult - Differential diagnosis includes pericarditis, myocarditis, acute coronary syndrome. Later in the day (~1530), had worsening chest pain and ST elevated noted on EKG. Pt did disclose at that time that he used cocaine about 8 days earlier. Pt transferred to Hospital for treatment of STEMI. Note: covid-19 vaccine info is pt reported, unable to access any Immunization records for this patient. Place where pt received vaccine is also unknown.
Information has been received from a physician via a pharmacist concerning a female adult who was vaccinated with a dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation).  Subsequently, the patient experienced an unspecified "alleged reaction."  Unspecified medical attention was sought.  Additional information has been requested.
Pt. given immunization 7/21/15. Pt. seen in ER 7/25/2015 after he was found unresponsive and having fallen out of bed. He was limp, "foaming at the mouth." When ambulance arrived he was postictal.-Convulsion or seizure event.
This child was exposed to children with chicken pox. He developed vesicles, pruritic rash on 04/18 on trunk. On exam he had papulovesicular rash on chest, back, upper arms - consistent with varicella. No fever. Pt appeared well. Only supportive care.
headache; injection site pain; body pain; fatigue; fever; chills; This is a spontaneous report from a non-contactable consumer (patient). A 20-year-old non pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number was not reported, expiration date was not reported), via an unspecified route of administration on 04Apr2021 (at the age of 20-years-old) as dose 2, single for covid-19 immunization at hospital. The patient medical history and concomitant medications were not reported. The patient historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number was not reported, expiration date was not reported), via an unspecified route of administration, administered in left arm on 14Mar2021 08:00 am (at the age of 20-years-old) as dose 1, single for covid-19 immunization at hospital and experienced injection site pain for 3 day. Patient did not receive any other vaccine in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. It was reported that on 04Apr2021 09:00pm the patient experienced injection site pain, body pain, fatigue, fever, chills for 3 days. headache for 5 days. The patient took some ibuprofen as treatment. Therapeutic measures were taken as a result of headache, injection site pain, body pain, fatigue, fever, chills. The outcome of the event headache was recovered on 09Apr2021 and outcome of events injection site pain, body pain, fatigue, fever, chills was recovered on 07Apr2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Asthma; My asthma symptoms reappeared; This is a spontaneous report received from a contactable consumer.   This 60-year-old male consumer (patient) reported for himself that he received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0153, Expiry Date: Unknown), via an unspecified route of administration, administered in left arm on 21Apr2021 at 15:30 (at the age of 60 years) as dose 2, single for covid-19 immunization. Patient had known allergies to Plaquenil. Other medical history included asthma which he had since childhood and it was well managed with albuterol and Advair. He only needed it occasionally, generally in early spring and autumn. When he started taking prednisone/Medrol and Xeljanz for his rheumatoid arthritis in 2015, his asthma symptoms disappeared completely. He had been asthma free for the past 5-6 years. The patient received the medication within 2 weeks of vaccination tofacitinib citrate (XELJANZ) taken for rheumatoid arthritis from 2015. Historical vaccine included he received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EP7534, Expiry Date: Unknown), via an unspecified route of administration, administered in left arm on 31Mar2021 at 15:45 (at the age of 60-year-old) as dose 1, single for covid-19 immunization. Prior to vaccination, the patient was not diagnosed with COVID-19. The most recent COVID-19 vaccine was administered at pharmacy or drug store facility. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 01May2021, at 12:00 Am, the patient asthma symptoms reappeared. The Patient reported that a couple of months ago, his asthma symptoms reappeared, coincident with his COVID-19 vaccination in April. He took his first dose of the Pfizer vaccine at the end of March and stopped taking Xeljanz for one week, on advice of his doctor. He also stopped taking Xeljanz for 1 week after the second dose on April 21st. On 01May2021 at 12:00 AM, he started experiencing asthma again and he now needed to take Advair and albuterol daily to keep it in check. The treatment received for the adverse event included Advair and albuterol daily to control asthma. The events were reported as non-serious. The outcome of the events not resolved.
Vaccine given at 8:15 AM. Child returned to clinic at 11:25 AM with 5 hive areas visible.
09/30/13: Patient reported local reaction left posterior upper arm following varicella injection on 09/27/13. Injection site red, warm, itchy, swollen measuring about 1.5' x 2'.
The pt developed red, tender and swelling (primary rxn) around the site of the vaccinia vaccination with lymphangitis; treated with Tequen 400mg X 5 days.
losing function of my arms/muscles extremely weak, couldn't get dressed on my own, or walk up a flight of stairs; losing function of my arms/muscles extremely weak, couldn't get dressed on my own, or walk up a flight of stairs; Dermatomyositis; This is a spontaneous report from a contactable other healthcare professional (patient). A 35-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 intramuscular, administered in Right Arm on 06Jan2021 (Batch/Lot Number: EJ3248) as single dose for covid-19 immunisation.  The patient medical history was not reported. Concomitant medication received within 2 weeks of vaccination included sertraline taken for an unspecified indication, start and stop date were not reported.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Pregnancy at time of vaccination: No. Facility where the most recent COVID-19 vaccine was administered: Hospital. The patient previously received first dose of bnt162b2 (brand= Pfizer, lot number= EJ1685,) via Intramuscular in Right arm on 06Jan2021 (as reported) at the age of 35-year-old for covid-19 immunisation. The patient experienced dermatomyositis on 02Feb2021, losing function of her arms/muscles extremely weak, couldn't get dressed on her own, or walk up a flight of stairs on Apr2021. Reported Event: In Feb. started getting patches of dry skin on the eyelids, and puffy underneath the eyes. By April the patient started losing function of her arms/muscles extremely weak, couldn't get dressed on her own, or walk up a flight of stairs. Went through multiple blood tests, MRI, CT, and muscle biopsy, in May she was diagnosed with the autoimmune disease, Dermatomyositis. Adverse event start date 02Feb2021. Treatment: Medication, high dose of a Steroid and Imuran. The adverse event result in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovering. Serious: Yes. Seriousness criteria-Results in death: No. Seriousness criteria-Life threatening: No. Seriousness criteria-Caused/prolonged hospitalization: No. Seriousness criteria-Disabling/Incapacitating: Yes. Seriousness criteria-Congenital anomaly/birth defect: No.; Sender's Comments: Based on the available information in the case, the causal association between the events dermatomyositis, loss of personal independence in daily activities, gait disturbance and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.  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.