chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Side effects; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Side effects) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Side effects). At the time of the report, VACCINATION COMPLICATION (Side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported. No treatment information was provided.
Around 7:00pm, approx. 7hrs after receiving my second vaccine my left arm (the arm I received my injection in) was extremely sore. As the evening progressed so did my discomfort & pain. By the time I went to bed I wasn't able to raise my left arm above my waist.  When I woke up @ 5am my joints were achy & I had a headache. Both of my feet were freezing.  Throughout the day on Tuesday, 2/2/21 my arm around the injection site continued to hurt & was fevered. I kept a headache all day. Today, Wed. 2/3/21 my left arm remains extremely painful in my upper arm. My left arm is swollen, red & fevered. There is a large 4.5in x 4.5in red, swollen, fevered area around the injection site. This is extremely painful & uncomfortable. I am worried the injection may have been administered subcutaneously instead of intramuscularly & may not be as effective as it should be. I spoke with the coordinator of ocupation health (who performs the vaccinations at my workplace). She advised me to submit this form.
Sweating, bloody stools, nausea.  Is currently a patient, as they do not know where he is bleeding from.  Currently in the ICU.
mild fever; Lethargy; chills; shaking; reduced appetite; .This is a spontaneous report from a contactable consumer or other non hcp. A 24-years-old (non-pregnant) female patient received bnt162b2 (BNT162B2, PFIZER BIONTECH COVID VACCINE, solution for injection, Batch/Lot number-not reported) via an unspecified route of administration, administered in Arm Left on 20Apr2021 12:00 as DOSE 2, SINGLE (at age 24-year-old) for covid-19 immunisation. Patient medical history included colitis ulcerative, anaemia, obesity, asthma exercise induced all were from an unknown date and unknown if ongoing. Patient had not diagnosed with covid prior vaccination and had not been tested covid post vaccination. Concomitant medications (medication within 2 weeks) included alprazolam (XANAX), omeprazole, alprazolam, fluoxetine all were taken for an unspecified indications, start and stop dates were not reported. Patient had not received any other vaccine in four weeks. Patient previously received dose 1 of BNT162B2, PFIZER BIONTECH COVID VACCINE, solution for injection, Batch/Lot number-not reported) via an unspecified route of administration, administered in Arm right on 30Mar2021 12:00 PM as DOSE 1, SINGLE for covid-19 immunisation. On 21Apr2021 at 12:00 AM (12 hours after the dose) patient experienced mild fever, lethargy, chills, shaking, reduced appetite. Severity is similar with a very mild flu. Needed to rest more, but able to continue work as usual. The outcome of events were not recovered.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report was received from a pharmacist via Pfizer, Inc. (2016558927) and refers to an unspecified number of patients of unknown demographics. The patient's concurrent conditions, medical history and concomitant medications were not reported. On unknown dates, the patients were vaccinated with doses of PNEUMOVAX23 (dose, route of administration, lot # and expiry date were not reported) for protection against pneumococcal pneumonia. Subsequently post vaccination, on unknown dates, the patients experienced fatigue. The outcome of the event was unknown. The reporter considered the event to be related to PNEUMOVAX23. Additional information has been requested.
On 3/11/12 he had pain radiating down his right arm (the arm in which he was vaccinated).  The next day the pain resolved, though he developed fatigue, weakness, abnormal gait, stiff joints and neck, migratory tingling sensations, dizziness, and difficultt concentrating.  This lasted through early May, then resolved.  He is now back to normal.
Gave Expired Dose of HEPLISAV-B; Initial Report Received on 20-Aug-2021  A pharmacist  reported that a patient (age, gender, race, and ethnicity not provided) received an expired dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization.   Relevant medical history was not reported.    Relevant concomitant medications were not reported.  On an unknown date, the patient received an expired dose of HEPLISAV-B (Lot #, expiration date, NDC #, and serial # not provided) from a nurse. At the time of reporting, no additional information was provided.  Company Comment:  The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Initial pregnancy information received on 22-Oct-2018 regarding an unsolicited valid non-serious case received from a consumer/non-HCP. This case involves a 43 years old female patient who received vaccine FLUBLOK QIV while she was pregnant. It was a case of vaccine exposure during pregnancy. Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known. The date of last menstrual period was 15-Feb-2018, the estimated due date is 18-Nov-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No concomitant medication received. On 19-Oct-2018, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE lot number not reported via unknown route in the left arm. On an unknown date, the patient felt more tired, had a headache, felt really hot and sweaty without fever, and was not feeling energetic following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE. (Other relevant tests included no lab tests). Final diagnosis was not feeling energetic, sweaty without fever, felt really hot, felt more tired and headache. No corrective treatment was received. The patient outcome is reported as Unknown for headache, as Unknown for feels more tired, as Unknown for feels really hot, as Unknown for sweaty but has no fever, as Unknown for not feeling energetic and as Not Applicable for vaccine exposure during pregnancy. Pregnancy outcome was unknown at the time of report. List of document held: none.
Patient experienced myalgias close after vaccine booster. Began to have fever (100.8) and headache on day 2 post-vaccine. Presented to Emergency Department on day 5 post vaccine with chest pain and was found to have elevated troponins. Patient was hemodynamically stable and ultimately discharged after an echocardiogram had normal ventricular function. Mother also mentions mild substernal/epigastric pain after the 2nd administration. (Had gotten an ECG and GI cocktail in the ED at that time).
Abdominal pain and diarrhea, no treatment as of yet. Started the night of the vaccine and has continued for 2 days and county. This was from a first dose.
palpitations; shortness of breath; ears burning; This is a spontaneous report from a contactable physician.  A 30-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on 04Jan2021 08:00 at single dose for COVID-19 immunization.  The patient medical history was not reported.  There were no concomitant medications.  The patient experienced palpitations on 04Jan2021 08:00, shortness of breath on 04Jan2021 08:00, ears burning on 04Jan2021 08:00. All events were nonserious.  It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within 2 weeks of vaccination. No treatment was received.  It was unknown if the patient diagnosed with COVID-19 prior to vaccination. the patient has not been tested for COVID-19 since the vaccination. No allergies to medications, food, or other products. The outcome of the events was resolved in Jan2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
fluzone high dose quadrivalent is given to a patient under the age 65 with no reported adverse event; Initial information received on 19-Sep-2023 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 49 years old female patient to whom fluzone high dose quadrivalent was given patient under the age 65 with no reported adverse event   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included tozinameran (comirnaty) for COVID-19 immunisation.  On 19-Sep-2023, the patient received suspect influenza quadrival A-B high dose HV vaccine lot U8044AB via intramuscular route in the left deltoid for prophylactic vaccination (strength, dose and expiry date: unknown), given to a patient under the age 65 with no reported adverse event (product administered to patient of inappropriate age) (latency same day).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event product administered to patient of inappropriate age.  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 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.
Pt returned to pharmacy 3 days after the vac. was administered displaying red-raised warm to touch area around inj. site. The area was spreading toward elbow about 2". Pt called her PCP and he prescribed BACTRIM DS.
Fever 102.5 p 22 hrs. Took MMR, IPV and DTaP at Heath Unit. Was on ABX x 2 days for dog bite.
Light bruising- worse near site of injection but bruises are appearing on other parts of my body as well
Canker sore in mouth; Roof of her mouth is very tender, when she eats the roof of her mouth, tongue and whole mouth hurts; The sore is all over her mouth; This spontaneous case was reported by a consumer and describes the occurrence of APHTHOUS ULCER (Canker sore in mouth), ORAL PAIN (Roof of her mouth is very tender, when she eats the roof of her mouth, tongue and whole mouth hurts) and ORAL PAIN (The sore is all over her mouth) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     Concomitant products included PRAVASTATIN and AMLODIPINE for an unknown indication.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced APHTHOUS ULCER (Canker sore in mouth), ORAL PAIN (Roof of her mouth is very tender, when she eats the roof of her mouth, tongue and whole mouth hurts) and ORAL PAIN (The sore is all over her mouth). At the time of the report, APHTHOUS ULCER (Canker sore in mouth), ORAL PAIN (Roof of her mouth is very tender, when she eats the roof of her mouth, tongue and whole mouth hurts) and ORAL PAIN (The sore is all over her mouth) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
Both sites on rt & lt thigh have area of induration & small bumps, around area of shot from knee to upper thigh; started Sunday evening p/bath 7-8PM; no other area of rash present;
Swelling, pain and inflammation of lymph nodes in left armpit lasting from 4/3/21 (the day after the second dose) through 4/7/21. Treated with ice, acetaminophen and message.   Massive changes to menstrual cycle. From 3 days in March to 6 days in April, very heavy flow with break-through bleeding (which I never had before), intense cramping lasting several days (brand new sympton, I don't get cramps usually). Since 4/2/21 my periods have been heavy and painful, nearly doubling in volume. I have always had a very light flow with little to no cramps/PMS. My period has not returned to normal yet.
Patient was vaccinated at 945, she took benadryl and famotidine immediately prior to vaccination. Patient then began to complain of "lightheadedness" and "palpitations." She also then began to complain of trouble swallowing. We escorted her to our triage area and obtained vitals. Oxygen Saturation maintained at 99-100% and the pulse ox remained on the patient the entire time. Initial BP was 138/82, and heart rate was staying in the 80's. Per patient and her son her heart rate is normally 50-60. Her blood pressure was checked multiple times with a downward trend. Her blood pressure is normally 100-110/60 per patient and her son.      Last blood pressure was 127/78, heart rate was 54 and o2 was 100%.   Patient stated all symptoms had resolved. Patient left the vaccination clinic at 1050 with her son, who is living with her and will be home.
Lymphadenopathy; This spontaneous case was reported by a physician and describes the occurrence of LYMPHADENOPATHY (Lymphadenopathy) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced LYMPHADENOPATHY (Lymphadenopathy). At the time of the report, LYMPHADENOPATHY (Lymphadenopathy) 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.   Concomitant details were not reported by the reporter. Treatment details was not reported by the reporter.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
I woke up on August 29, 2022, not feeling good. I had not felt like this for years. I took a home COVID-19 test and it came back negative, took a generic Naproxen and went to work. While I was at work a friend who had spent the went the weekend called and to let me know that he had tested positive for COVID-19. I went home immediately and tested again, my results came back positive. I called my doctor's office but they were closed and I was advised from the afterhours service to to go to Urgent Care. She retested me, it came back positive, advised me to increase my Vitamin D, Tylenol,  gave me a prescription for Paxlovid, that I started that night. I did get rebound COVID-19. I do still have a small cough.
Skin peeling off arms(less so?mostly flaking) and legs. Enough sloughing off to create a snow mound.  Trunk not affected.  Noticed 48 hours after shot but did not think anything of it.   Peeling skin increased.  Purchased Nivea intensive healing lotion on Saturday and started applying liberally.  Peeling/flaking gradually declined.  Minor flaking on legs currently.
A few hours after my booster shot, I was tired and took a nap. I woke up at 3pm and realized I had started bleeding. Between 3-5pm I was bleeding heavily, that leveled off in the evening, and then I continued to bleed for a week.   I was pregnant at the time of receiving my booster shot. My HCG levels as measured on 12/9/21 were 97.0 mIU/mL. Based on the first date of my last period (11/10/21), it is estimated I was about seven weeks pregnant at the time of my booster.
arm pain; headache; chills; intermittent fever/,fever 100.7; fatigue; This is a spontaneous report from a non-contactable other health care professional (Patient). A 54-years-old not pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number and Expiry date was not reported), via an unspecified route of administration on 24Mar2021 08:30 (at the age of 54-years-old) in Arm Left as dose 1, single for COVID-19 immunization. The Patient Medical history was no. Concomitant medication(s) in two weeks was levothyroxine (LEVOTHYROXINE) taken for an unspecified indication, start and stop date were not reported. The patient previously took roxicet and experienced Drug allergy. The patient did not received other vaccine in four weeks. The Patient was diagnosed with COVID prior vaccination. The Patient did not tested COVID post vaccination. On Unspecified date, the patient experienced arm pain, fever 100.7, headache, chills-intermittent fever, fatigue between vaccinations. The Patient did not received treatment for the events. The patient underwent lab tests and procedures which included body temperature: 100.7 on. The outcome for the events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
starting on 3/27/2021: right arm slightly sore at injection site. Lethargy/mental fogginess. Joint aches, especially in the low back/hip region. Hypersensitive skin, especially to the thoracic region. Slight pressure in head, not bad like a headache, but still present.
Bell?s Palsy Loss of feeling left face Drooping face eye and mouth Difficulty swallowing, closing left eye After first vaccine dose Prednisone pills
nausea 7 minutes later .  chills 10 minutes later.   EMT came and walk out with patient at 12:28pm
Floating stool starting one month after 2nd dose. Has continued to present time. No other symptoms. Had abdominal ultrasound-June 2021-  normal   All routine blood work, urinalysis , occult stool test normal. No further follow up. Stool continues to float with every BM.
Information has been received from a physician referring to a patient of unknown age and gender.  Information about concurrent condition, concomitant medication and medical history was not provided. On 27-OCT-2017 the patient was vaccinated with expired dose of PNEUMOVAX 23 (lot # M013156, expiration date 15-OCT-2017) (dose and route were not reported) for prophylaxis (expired product administered). No adverse effects were reported.
administered dose lower than authorized dose of the Moderna COVID-19 bivalent booster/ Patient was administered 0.25 ml instead of 0.5 ml; No adverse event; This spontaneous case was reported by a physician and describes the occurrence of ACCIDENTAL UNDERDOSE (administered dose lower than authorized dose of the Moderna COVID-19 bivalent booster/ Patient was administered 0.25 ml instead of 0.5 ml) and NO ADVERSE EVENT (No adverse event) in an elderly 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) .25 milliliter. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (administered dose lower than authorized dose of the Moderna COVID-19 bivalent booster/ Patient was administered 0.25 ml instead of 0.5 ml) and NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (administered dose lower than authorized dose of the Moderna COVID-19 bivalent booster/ Patient was administered 0.25 ml instead of 0.5 ml) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (administered dose lower than authorized dose of the Moderna COVID-19 bivalent booster/ Patient was administered 0.25 ml instead of 0.5 ml).    No concomitant product reported by reporter. It was reported that, the nurses had no standing orders other than what they had for the second booster when they first administered the Bivalent booster. So, they assumed the same dose as the second booster, hence they had administered 0.25 ml instead of 0.5 ml to uncompromised patient. They administered an invalid dose which was lower than authorized dose of the Moderna COVID-19 bivalent booster. No treatment medication reported by reporter.
Right arm pain; headache; fatigue; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 43-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Sep2022 at 18:30 as dose 4 (booster), single (Lot number: GH9693) at the age of 43 years intramuscular, in right arm for covid-19 immunisation. The patient's relevant medical history included: "HTN" (unspecified if ongoing); "IBS" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL; OMEPRAZOLE; LINZESS. Vaccination history included: Covid-19 vaccine (Primary Immunization series completed;  unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (Dose 3 (booster), Single), for COVID-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 22Sep2022 at 07:00, outcome "recovering", described as "Right arm pain"; FATIGUE (non-serious) with onset 22Sep2022 at 07:00, outcome "recovering"; HEADACHE (non-serious) with onset 22Sep2022 at 07:00, outcome "recovering". Therapeutic measures were not taken as a result of pain in extremity, headache, fatigue.  Additional information: No known allergies. No covid prior vaccination. No covid tested post vaccination. No other vaccine in four weeks. Other medical history: HTN, IBS. Other medication in two weeks: lisinopril, omeprazole, linzess and MVI. Facility type vaccine was pharmacy or Drug Store.