chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt reported feeling like fainting after flu vaccine, pt was laid on a floor with her legs up. After 10 minutes pt reported feeling better, gave pt cold water, ice pack. Husband of the pt came to pick her up, pt. walked slowly to the car feeling better.
On 2/22 I developed fever, fatigue, horrible muscle aches and general not feeling well. On Sat 3/28/21 I developed very large red hive like lesions all over my neck, under ears, and one very large one on my left side.  These lasted for 4 days. They were very large welt line lesions but were nit itchy like hives. I also developed some vaginal spotting. I also became very flushed and very hot and fatigued with any excercise despite not having fever except for second day. I have pictures of these red hive like spots
I began to have fever, chills, muscle aches, joint aches, and rapid heartbeat.  They lasted approximately 36 hours.
COVID-19 Moderna Arm - large tough red patch spreading over most of upper left arm, painful to the touch and swollen- ongoing at time of submission  High Fever- April 3-4 high fevers all day ranging from 101-103 both days  Severe headache- starting same afternoon of the shot, intense, light sensitive headache
Menstruation lasted 6 weeks. I am a healthy, 30 year old woman on birth control. I took the Pfizer booster shot on December 7th, 2021 at a pharmacy. I had previously had my two shots earlier in 2021. I regularly take the birth control pill. I got my menstrual cycle on December 15th and experienced a very heavy cycle for 6 weeks. 6 weeks of bleeding and spotting and daily stomach cramps. My period ended January 23. I did not seek medical help or advice. I did not miss a birth control pill.
Pt stated on 11/10/16 that arm of injection site was red, warm, and hard below the injection site area. On 11/11/16 patient came in to show pharmacist and arm was red and warm. Patient was sent to the MD. Patient reported that MD said it was a localized reaction without infection and instructed patient to take Benadryl and a cold compress.
Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Nov-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 19-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 19-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Unknown      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant and treatment drugs were provided.   This case was linked to MOD-2021-391981 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 23-Nov-2021: Follow-up received: Reporter information was added, patient details and product details updated.
Pleuritic chest pain in left parasternal area upon inhalation starting 1/12/2021 at ;7:30 am.  I went to ER. Given chest x-ray, EKG and blood.  All negative; to have cardiac treadmill morning of  1/13/2021.   Pelvic pain started 19:00 1/12/2021 when I returned from ER.
just a little bit of a sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (just a little bit of a sore arm) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Feb-2021, 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 (just a little bit of a sore arm). At the time of the report, PAIN IN EXTREMITY (just a little bit of a sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided.  Treatment information was not provided.   This case was linked to MOD-2021-329129 (Patient Link).
Slight swelling of back of tongue.  Enough to repeatedly clear my throat. Felt like I had phlegm stuck in throat and tried to clear it out.  Started about 5 minutes after shot and lasted about 30 minutes
Information has been received from a pharmacist concerning a female consumer. The pharmacist reported a patient received her first dose of GARDASIL about a year ago and mentioned the patient was in the office on 01-OCT-2012 to receive her second dose of GARDASIL. No adverse symptoms were reported. No further information provided. Additional information has been requested.
Mother reports child had a seizure (her first ever) that lasted several minutes. No temperature was taken. After seizure child suffered no other effects and was fine. She was not taken to the PCP or ER.
Hospitalized February 28, 2021 with acute cerebrovascular accident with left hemiparesis, 4 days after vaccine
Low grade fever, Chills, myalgia, fatigue, headache - onset 19 hours after vaccine administration in the order listed.  Duration: low grade fever, chills, myalgia, fatigue lasted 8 hours. Headache lasted 2 days, intermittent. Treatment: Tylenol for myalgia and low grade fever.
cellulitis @ site of inj 5 1/2cm x 3 1/2cm;Duricef-Motrin
BABY STARTED SCREAMING AND CRYING, AND STOPPED TAKING HER BOTTLE. THIS CARRIED ON FOR 2 WEEKS STRAIGHT.
pt recv vax & 36hrs p/vax devel abd gas,swelling & pain & an intolerance to lactose,lecithin,& breast milk;mom subsequently discontinued breastfeeding;pt's exp required ER or MD visit;pt put on feingold diet;mom reports pt doing much;
Fever 102, diarrhea,  nausea, tachycardia,  hypotension, weakness, fatigue, body ache, chills. Started  5 hours after the vaccine and lasted 72 hours. This happened after both the first and second vaccine
Seizures:  Body involuntarily shook, eyes rolled back into his head intermittently for several minutes on and off for about 6 hours.  102 degree fever, inconsolable crying. Toxic smelling diapers, refusal to eat, sleeping for 18 hours straight just like the last vaccine when her got DTaP.
February - June Serious headache, at least one/day for >30 minutes and up to 6 hours. Intense pain in forehead above eye, round to temple and up to crown of head Saw PCP in May, recommended Magnesium supplements June - Current Taking magnesium supplements, headache intensity and duration has decreased but still present >3 times / week
Swollen (L) anterior thigh extending to the left knee. Erythema noted. Had a previous reaction to last year's vaccine (R) upper arm (received vaccine in different place). Was tested for allergy to egg and deemed not to be allergic per allergist. Had two flu vaccine doses in 2015, and did not have any reaction then. Not yet seen in office 12/6/18.
Sustained fever between 101-102  and body tremors for 24 hours.  First 48 hours also included severe body aches, lethargy, sensation of lungs burning, visibly swollen glands.  Lethargy and the sensation of lungs burning or ?heart burn? counties for five days after the vaccine.
Fever - treated with OTC (Motrin, Tylenol) Lethargy - treated with rest  Symptoms cleared within 24 hours
AFib; This spontaneous case was reported by a consumer and describes the occurrence of ATRIAL FIBRILLATION (AFib) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced ATRIAL FIBRILLATION (AFib) (seriousness criterion medically significant). At the time of the report, ATRIAL FIBRILLATION (AFib) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication details was reported. No treatment medication details was reported.  Company comment: This spontaneous case concerns an adult patient of unknown gender with no reported medical history who experienced the unexpected serious (medically significant) AESI of Atrial fibrillation which occurred unknown days after receiving a dose of mRNA-1273.222 bivalent vaccine. Event outcome was unknown at the time of the report. The benefit-risk relationship of mRNA-1273.222 bivalent is not affected by this report   This case was linked to US-MODERNATX, INC.-MOD-2023-719403 (Linked Report).; Reporter's Comments: Company comment: This spontaneous case concerns an adult patient of unknown gender with no reported medical history who experienced the unexpected serious (medically significant) AESI of Atrial fibrillation which occurred unknown days after receiving a dose of mRNA-1273.222 bivalent vaccine. Event outcome was unknown at the time of the report. The benefit-risk relationship of mRNA-1273.222 bivalent is not affected by this report; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-719403:This case is for Doctor 2 out  of 2 doctors
Patient still had not gotten her 2nd dose - over 36 days after 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Patient still had not gotten her 2nd dose - over 36 days after 1st dose) in a female 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Patient still had not gotten her 2nd dose - over 36 days after 1st dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Patient still had not gotten her 2nd dose - over 36 days after 1st dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication and treatment were not reported.
red rash at the injection site; itching at the injection site; pain at the injection site; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 11-Feb-2021 and was forwarded to Moderna on 11-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (itching at the injection site), VACCINATION SITE RASH (red rash at the injection site) and VACCINATION SITE PAIN (pain at the injection site) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     The patient's past medical history included Lumbago and Cholesterol. Concomitant products included RANITIDINE for Cholesterol, DICLOFENAC and IBUPROFEN for Lumbago.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced VACCINATION SITE PAIN (pain at the injection site). On 09-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (itching at the injection site). On 10-Feb-2021, the patient experienced VACCINATION SITE RASH (red rash at the injection site). At the time of the report, VACCINATION SITE PRURITUS (itching at the injection site), VACCINATION SITE RASH (red rash at the injection site) and VACCINATION SITE PAIN (pain at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient was taking an unspecified medicine for cholesterol, along with ranitidine (details not provided). The patient reported that following her first shot of COVID vaccine, she experienced pain at injection site. On 09-Feb-2021, she experienced her arm at the injection site was itchy and the following day, she noticed a red itchy rash at the injection site. Reportedly, she did not receive any treatment for the symptoms, however was curious to know if these symptoms were normal or not.
Missed 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Missed 2nd dose) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014F21A) for COVID-19 vaccination.     Concurrent medical conditions included Dementia.    On 13-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed 2nd dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Missed 2nd dose) had resolved.            No concomitant medication details was reported. No treatment medication details was reported.  The patient had been cancelling second dose appointments right before going in. It has already been 2 months since first dose, so reporter was wondering if patient needs to start the vaccine series all over again.
Diagnosed with Transverse myelitis; Numbness; Paresthesia; Progressed to a point that the patient can no longer walk and no is on wheel chair; Progressive weakness in lower extremities and worked its way up to mid torso/ Weakness; This spontaneous case was reported by a health care professional and describes the occurrence of MYELITIS TRANSVERSE (Diagnosed with Transverse myelitis) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044A21A and 030M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in January 2021. Concomitant products included ROSUVASTATIN, ASPIRIN [ACETYLSALICYLIC ACID], UBIDECARENONE (COQ10 [UBIDECARENONE]) and PANTOPRAZOLE for an unknown indication.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2021, the patient experienced MYELITIS TRANSVERSE (Diagnosed with Transverse myelitis) (seriousness criterion medically significant), HYPOAESTHESIA (Numbness), PARAESTHESIA (Paresthesia), GAIT INABILITY (Progressed to a point that the patient can no longer walk and no is on wheel chair) and ASTHENIA (Progressive weakness in lower extremities and worked its way up to mid torso/ Weakness). The patient was treated with METHYLPREDNISOLONE at an unspecified dose and frequency. At the time of the report, MYELITIS TRANSVERSE (Diagnosed with Transverse myelitis), HYPOAESTHESIA (Numbness), PARAESTHESIA (Paresthesia), GAIT INABILITY (Progressed to a point that the patient can no longer walk and no is on wheel chair) and ASTHENIA (Progressive weakness in lower extremities and worked its way up to mid torso/ Weakness) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, Magnetic resonance imaging: abnormal (abnormal) Diagnosed with Transverse Myelitis.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was not applicable.  Company comment: Based on the current available information which shows a temporal association between the use of mRNA-1273 and the onset of the reported events, a causal relationship cannot be excluded. Further details regarding medical history and treatment for assessment.   Most recent FOLLOW-UP information incorporated above includes: On 22-Jun-2021: Follow up received on 22-JUN-2021 contains Non-Significant information.; Sender's Comments: Based on the current available information which shows a temporal association between the use of mRNA-1273 and the onset of the reported events, a causal relationship cannot be excluded. Further details regarding medical history and treatment for assessment.
never pushed the plunger down while administering the vaccine; patient might not have received the vaccine; A Spontaneous report  was received from a husband and wife, concerning the wife, a female consumer of unknown age who was participating in the mRNA-1273 Emergency Use Program and when they were administering the vaccine to her, they never pushed the plunger down, and the patient might have not received the vaccine  The patient's medical history was not provided. No relevant concomitant medications were reported.   On an unknown date, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   On an unknown date, while administering the vaccine to the patient they never pushed the plunger down and the patient might have not received the vaccine (the reporter want to know if they received the vaccine).  Action taken with mRNA-1273 in response to the events was not reported.  The events, of when they were administering the vaccine to her, they never pushed the plunger down, and the patient might have not received the vaccine were considered resolved on an unknown date.; Reporter's Comments: This report refers to a case of wrong technique in device usage process and incorrect dose administered for mRNA-1273.  There were no reported adverse events associated with this case.
pt devel redness, swelling of lt deltoid area;seen in clinic 21MAR afeb;lt deltoid area warm, red, not tender;seen again 22MAR still afeb but w/progression of erythema;adm to hosp for presumed cellulitis;
This case was reported by a pharmacist and described the occurrence of injection site hemorrhage in a subject of unspecified age and gender who was vaccinated with influenza virus vaccine (Fluarix) for prophylaxis. On 23 October 2006 the subject received unspecified dose of Fluarix. The pharmacist reported that, on 23 October 2006, less than one day after vaccination with Fluarix, "there was blood on the needle" upon withdrawal from the subject. The pharmacist noted that the nurse who injected the Fluarix "was not sure if Fluarix was injected intravenously or not". The outcome of the event was not reported. The pharmacist considered the event was probably related to vaccination with Fluarix.
Patient had his first vaccination on 3/31/21 (pfeizer).  On 4/09/21  he felt tired and went to bed early at 9pm.  He  woke up at 9:45pm to major chest pains.  We called 911 and he was immediately transported to ER.  He had elevated tropinon levels (1.11) and was diagnosed as having a heart attack.  They completed an angiogram and didn't find any clogged arteries.  His organs looked good and his tests didn't show any abnormalities.  He was released 2 days later.  He was given 8 medications to take to monitor his new heart issues.  Two weeks later, on 4/23/21 he had chest pains at 6:30am in the morning and was hospitalized. He was monitored in the hospital and was later released on 4/25/21.  That evening (on 4/25) he experienced chest pains again and returned to the hospital.  He was treated for heart attack. More medication changes were made.  He has had multiple chest pains since and dr. have referred to them as "spasms".  He was admitted to the ER on 5/24 for excruciating chest pains and his medications were adjusted.  He has had "spasms" every two weeks since and his last hospitalization was on  6/25/21 for "spasms".  His current medication list incudes:  isosorbide, ranolazine, amlodipine, atorvastatin, clopidogrel, diltiazem, nitroglycerin (as needed), escitalopram.
Woke in the early night  the day after vaccine with a very rapid, irregular, pounding heart beat. I have a history of benign palpitations, but this felt more acute. I went to ER and was diagnosed with Atrial Fibrillation with elevated troponins. Converted to regular rhythm after 3 doses of diltiazem IV.  Was given Eliquis orally. I am now on diltiazem and Eliquis after being on no meds for 70 years. I feel that this is related to the mRNA vaccine. I think Novavax would have been a better choice for me as an older adult. :-( I hope these symptoms resolve and I can wean off medications. ER Visit last night for panic due to this overwhelming new diagnosis. In ER 10/21 I had an elevated BP but no a fib, and a normal sinus rhythm. Happy to give more info anytime. Thank you!
Vaccine administered after temperature excursion; Vaccine administered after temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered after temperature excursion) and PRODUCT STORAGE ERROR (Vaccine administered after temperature excursion) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered after temperature excursion) and PRODUCT STORAGE ERROR (Vaccine administered after temperature excursion). On 02-Apr-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine administered after temperature excursion) and PRODUCT STORAGE ERROR (Vaccine administered after temperature excursion) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  Treatment information was not provided.
Severe muscle aches, chills and fever of 105.9 Substantial pain and swelling at injection site.
Dose No. 1 on 01/26/2021 - No Reactions/Side Effects  Dose No. 2 on 02/23/2021 - No initial Reactions/Side Effects.  On 03/03/2021, 8 days after Dose No. 2, I developed a sizeable rash at, and surrounding the injection site on left arm.  I note skin is warmer than usual at injection site, slight swelling and mild itching.  I have no fever or other side effects.  Since this is just day two after developing the rash I have not yet recovered from the reaction.