chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Shortly after receiving my Covid shot,  my menstrual cycle returned early which is unusual.  Since then every period has been longer, changed in consistency and amount. I now experience menstrual cycle side affects I have never had before from cramps, inner pain in my groin area and longer cycles. I experience severe menstrual cycle cramps before, during and after my menstrual cycle has dissolve in which I never had an issue before.
Fatigue, 2 -3 days. Shivering, 1 day. Redness at injection site, 3 days. Frequent urination with excessive hunger, 1 (7 hours overnight).
Right eye inner canthus swelling beginning on 09/09/2018 with increased periorbital swelling by end of day. Left arm injection site discomfort but no skin reaction. Awakened on 09/10/2018 with both eyes swollen, right more than left. Papular type rash on both sides of face to include cheeks and chin. Painful.
Dizziness; Unable to stand up; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness) and DYSSTASIA (Unable to stand up) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, the patient experienced DIZZINESS (Dizziness) and DYSSTASIA (Unable to stand up). At the time of the report, DIZZINESS (Dizziness) and DYSSTASIA (Unable to stand up) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided the reporter. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 02-Aug-2021: Non-significant follow-up received.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Hands have broken out in a psorias type condition. Itching and dry skin on knuckles with breakthrough bleeding and sores
Redness extending about 3 inches down arm below site of injection.  Mild swelling and tenderness about 2 inch radius around site, mild itching.   Had a more extensive red area after the second shot and expect the area to increase over the next day based on previous progression
pt inject site showed edema, heat & severe redness; hard to touch; area encompassed approx 7" diameter area of humeral tissue mass; rx cold compresses; APAP given; DPH for itching;
pt recv vax 10AM & rash was noticed by another individual @ 1PM on neck, chest, back (upper torso) pt otherwise asymptomatic;pt presented back to place of vaccine administration @ 130PM;rash non itching;tx w/Benadryl;
red spot around injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (red spot around injection site) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015AM20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (red spot around injection site). At the time of the report, VACCINATION SITE ERYTHEMA (red spot around injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not reported.
1st day - red, rash on arm that spread to about the size (6" x 6"), pain in armpit of arm she received vaccine. 2nd day - started to itch & burn, HA (pt stated not unusual for her), pt still reports rash w/ occasional itching 2 wks post vaccination.
Headache following booster for 2 days. Found to have thrombocytopenia and hemorrhagic stroke when presenting to the ER 2 days after vaccine.
Information has been received from a registered nurse concerning a 8 year old female patient who on an unspecified date was vaccinated with 0.5ml dose of VARIVAX (Merck) (lot# not reported). On an unspecified date, the patient broke out with chickenpox. On an unspecified date the patient recovered from chickenpox. The patient sought unknown medical attention. Additional information has been requested. The patient's sibling also experienced chickenpox after receiving 0.5ml dose of VARIVAX (Merck) (WAES # 1009USA00415).
COVID-19; COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32-year-old male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "Obesity" (unspecified if ongoing); "Diabetes" (unspecified if ongoing); "Known allergies: Shrimp" (unspecified if ongoing), notes: Known allergies: Shrimp and mango; "Known allergies: mango" (unspecified if ongoing). Concomitant medication(s) included: ACETAMINOPHEN; GUAIFENESIN; DEXTROMETHORPHAN; PHENYLEPHRINE; LISINOPRIL; HYDROCHLOROTHIAZIDE; PAROXETINE; OMEGA 3 [DOCOSAHEXAENOIC ACID;EICOSAPENTAENOIC ACID;TOCOPHEROL]. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Anti-viral details, Product COVID 19 Treatment, Brand Paxlovid, Treatment start date 11Aug2022, Treatment stop date 15Aug2022. Other medication in 2weeks product Vegan multivitamin.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
atrial fibrillation; Pericarditis; pleural effusion; This spontaneous case was reported by a physician and describes the occurrence of ATRIAL FIBRILLATION (atrial fibrillation) and PERICARDITIS (Pericarditis) in a 60-year-old patient of an unknown gender 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 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 ATRIAL FIBRILLATION (atrial fibrillation) (seriousness criterion medically significant), PERICARDITIS (Pericarditis) (seriousness criterion medically significant) and PLEURAL EFFUSION (pleural effusion). At the time of the report, ATRIAL FIBRILLATION (atrial fibrillation), PERICARDITIS (Pericarditis) and PLEURAL EFFUSION (pleural effusion) 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.   No concomitant products were reported. No treatment drugs were reported.  Patient had no cardiac history.  Company comment: A physician reported a 60-year-old patient (sex not specified) with no cardiac history, who experienced the Expected event of Pericarditis; and Unexpected events of Atrial Fibrillation and Pleural Effusion. The events occurred at unknown interval after a dose of mRNA-1273 (Moderna Covid-19 vaccine). The rechallenge was not applicable, as the event happened after a dose. Limited information provided precludes a complete medical and causal assessment of this case. The benefit-risk relationship of mRNA-1273 (Moderna Covid-19 vaccine) is not affected by this report.   This case was linked to MOD-2021-363486 (Patient Link).; Sender's Comments: A physician reported a 60-year-old patient (sex not specified) with no cardiac history, who experienced the Expected event of Pericarditis; and Unexpected events of Atrial Fibrillation and Pleural Effusion . The events occurred at unknown interval after a dose of mRNA-1273 (Moderna Covid-19 vaccine). The rechallenge was not applicable, as the event happened after a dose. Limited information provided precludes a complete medical and causal assessment of this case. The benefit-risk relationship of mRNA-1273 (Moderna Covid-19 vaccine) is not affected by this report.
only had one and that was probably years ago, never been so sick in my life; Initial information received on 18-Nov-2022 regarding an unsolicited valid Social Media non-serious case received from a Consumer/Non-HCP.  This case involves an unknown age and unknown gender patient who only had one and that was probably years ago, never been so sick in my life after receiving INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a  dose of influenza vaccine produced by unknown manufacturer (form, strength, dose, frequency, lot number, expiry date: unknown) via unknown route in unknown administration site for Prophylactic vaccination  On an unknown date the patient only had one and that was probably years ago, never been so sick in my life (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (only had one and that was probably years ago, never been so sick in my life).  At time of reporting, the outcome was Unknown for the event.
Expired Moderna vaccine was given to patients; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired Moderna vaccine was given to patients) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009c21a) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired Moderna vaccine was given to patients). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired Moderna vaccine was given to patients) had resolved.        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.   Caller states expired Moderna vaccine was given to patients and wants to know what to do. Five patients received vaccine on 2dec2021 from lot 009c21a. Published expiry date is 15oct2021. Please see attached document for patient identifiers.  No concomitant medications was reported. No treatment drug details was reported.
This spontaneous report as received from a registered nurse refers to a 2 month old patient. On 28-FEB-2013, the patient was vaccinated with a dose of PNEUMOVAX23 (route and lot # not reported). No symptoms were reported. Additional information has been requested.
Arthralgia, Fever, injection site discomforts - redness (41mm X 52mm) in diameter, site hot with inflammation, c/o chills, fatigue, right chest wall sharp pains Narrative: is seeing the Employee Health provider - employee has taken Benadryl, Motrin and Tylenol - no meds given at this visit. Instructed to continue to monitor injection site for increasing redness, swelling. Instructed to seek outside care through local ER or urgent care if chest discomforts continue or worsen
Pt complained of tightness in chest, spots/rash on extremities.  Dr at Medical Center reported general vaccinia that will be self limiting.  Dr provided info from CDC.
headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a  sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 06Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications.  The following information was reported: HEADACHE (non-serious) with onset 06Mar2021, outcome "unknown", described as "headache". Therapeutic measures were taken as a result of headache: took ibuprofen.  No follow-up attempts are possible. No further information is expected.
Arm slightly red. About 2-3 inches wide and about 7 inches long: warm to touch. Slight bump where injection occurred. Does not hurt.
No covid symptoms were reported by this case. Case experienced severe pain, swelling and numbness in his leg. He drove himself to the hospital and once there tested positive for COVID. Case is now being treated for blood clots in his leg.
i have the flu; sick; Initial information received on 28-Dec-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves an unknown age and unknown gender patient who experienced flu and sick after receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number, expiry date: unknown) not reported via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious i have the flu (influenza) and sick (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  Action taken with INFLUENZA VACCINE was not applicable.  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, the outcome was Not Recovered / Not Resolved for both the events.
Rash on face, neck, and chest. Hives at injection site. No SOB reported.
3/18/21 rash with mild itching and pain appeared on left arm. Severe pain in neck area (left side) and pain under left armpit 3/21/21 blisters appeared at rash site. Blisters burst and returned for 5 days. 3/22/21 visit PCP. Started 10 days of Cephalexin 500mg 2 x day.  Ordered  bloodwork and ultrasound of thyroid area for neck pain (thought it was thyroiditis)
Flu; Initial information regarding this unsolicited valid non-serious social media case received from a consumer (patient) on 04-Dec-2020.  This case involves a patient with unknown demographics who experienced flu (Influenza) when received vaccine INFLUENZA VACCINE.  Relevant medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, (unknown latency) the patient the only ever had the flu (Influenza) when the patient, following the administration of INFLUENZA VACCINE (flu shot). Moreover, the patient sick for 4 days and only flu shot the patient ever had and he/she was sure won't got another one.  Relevant laboratory test not reported.  It was not reported if the patient received a corrective medication.  At the time of reporting, the outcome was unknown for the reported event.  There will be no information available on batch number for this case.
Patient is complaining of severe pain in her arm. She can't raise her arm to get dressed or comb her hair. She said the pain started soon after her vaccine. She was in tears and says she has had to take time off from work due to the pain. She has tried anti-inflammatory and heat and cold and nothing helps.
Fever, chills, myalgia, headache.  All subsided at 12:15 AM on 09/24/2016.
TOPICAL REACTION, RED, SLIGHTLY SWOLLEN/RAISED, WARM TO TOUCH, LIGHT RED BORDER, ABOUT THE SIZE OF 50 CENT PIECE, REPORTED 4 DAYS AFTER VACCINATION.
administration of the vaccine which was more SubQ than going into the muscle, with no reported adverse event; Initial information received on 26-Jul-2023 regarding an unsolicited valid non-serious case received from a Nurse.  This case involves an unknown age and unknown gender patient who had administration of the diphtheria-2/tetanus/5 AC pertussis vaccine [Adacel] which was more subq (subcutaneously) than going into the muscle, with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received an unknown dose of suspect diphtheria-2/tetanus/5 AC pertussis vaccine Suspension for injection (lot number, strength, expiry date, administration site- not reported) for Prophylactic vaccination, which was more subcutaneous than going into the muscle, with no reported adverse event (incorrect route of product administration) (latency- same day). Information on the batch number was requested.  Reportedly, Caller stated that they administered the vaccine to a patient, and it was more SubQ than going into the muscle. Caller wanted to know if the vaccine should be given again since it did not go into the muscle.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Initial information received on 09-Oct-2018 regarding an unsolicited valid non serious case received from a Nurse Practitioner. This case involves female patient of an unknown age who was received vaccine ADACEL via subcutaneous route back in the arm (batch number, expiry date and dose were not reported) on 05 Oct 2018, while she was pregnant. The date of last menstrual period was not reported. The estimated due date was not reported. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was case of vaccine exposure during pregnancy. The patient was 28 weeks and 6 days pregnant when she received vaccine. It was an actual medication error due to Vaccine administered at inappropriate site and Inappropriate route of vaccination. The Medical Assistant who gave her the injection did not give the injection IM. It was given SC further back in the arm than the Deltoid muscle. It was unknown whether patient experienced any adverse reaction after vaccination. Pregnancy outcome was unknown at the time of report. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender- none.
This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and unknown gender. The patient pertinent medical history was not reported. On 30-JUL-2014, the patient was vaccinated with VARIVAX (Merck) (dose strength and route was not reported) (lot # J014131 and expiry date: 07-NOV-2015, reported as 01-JUL-2015) which was improperly stored. Primary reporter was reporting excursion of 6 F since 01-JUN-2013 (confirmed date) affecting VARIVAX (Merck), nurse also reported that products were not stored in an overall average support range of -58 degree F and 5 degree F. No adverse effects reported. No product quality complaint (PQC) was reported for VARIVAX (Merck). This is one of the several reports from the same reporter. Additional information has been requested.
Patient received his last Pfizer COVID shot on August 23, 2021. He was not due for the Moderna booster he received on 11/22/21, being 3 months early.
Pneumonia; 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 PNEUMONIA (Pneumonia) 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 PNEUMONIA (Pneumonia). At the time of the report, PNEUMONIA (Pneumonia) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications was provided.  Treatment information was not provided.  Company Comment: Very limited information regarding this event has been provided at this time. No further information is expected at this time.; Sender's Comments: Very limited information regarding this event has been provided at this time. No further information is expected at this time.
Pt. began to experience flushing as well as tingling sensation in his tongue. Pt. reports tongue felt as if he had eaten something spicy. Pt denied difficulty breathing, throat closing up, swelling of the lips or tongue. Vital signs reviewed and WNL. Pt reports symptoms were subsiding with further evaluation and pt. dc' d home with precautions given.
the day after my shot i had  chest pain that felt like my bones needed to pop and the pectoral muscles were extremely sore and had a hard time lifting both arms due to the pain.  Took tylenol and it did not help at all.  The intense pain lasted that day and did ease up  somewhat the following day but was still sore with a dull achy pain, and today is the 3rd day and still just a little sore in the chest area
Mother states that after 1 hour of the vaccine administration, patient vomited twice and had temperature of 39.7.
p/vax pt w/inj site erythema & swelling, h/a, neck pain & body aches;
Onset of bilious vomiting, abd. bloating, pain - ER admitted - multiple tests run (x-rays, labs) - no etiology - remains fussy, spitting more - mother feels fussiness started after immunizations. 1/14/09-records received for DOS 1/5-1/6/09 DC DX: Bilious Vomiting. Irritability. metabolic acidosis. Abdominal pain, generalized. Shock. Presented to ED with C/O spitting up, acute onset of bilious emesis, extreme fussiness. Vomiting, dry heave. Nauseous. Watery diarrhea. Pale.
Redness, Black and blue spots, hot to the touch, within 2 hours, after administration of injection
09/10/22 presents to ED for "dizziness" PMHx of "HTN, hyperlipidemia, ischemic CMP, CAD/CABG"