chrisvoncsefalvay/vaers-outcomes huggingface dataset:
arm swollen; arm red; arm itchy; Felt hardness, like she's been stung by a bee; arm painful; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 09-Apr-2021 and was forwarded to Moderna on 09-Apr-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (arm swollen), ERYTHEMA (arm red), PRURITUS (arm itchy), VACCINATION SITE INDURATION (Felt hardness, like she's been stung by a bee) and PAIN IN EXTREMITY (arm painful) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, the patient experienced PERIPHERAL SWELLING (arm swollen), ERYTHEMA (arm red), PRURITUS (arm itchy), VACCINATION SITE INDURATION (Felt hardness, like she's been stung by a bee) and PAIN IN EXTREMITY (arm painful). At the time of the report, PERIPHERAL SWELLING (arm swollen), ERYTHEMA (arm red), PRURITUS (arm itchy), VACCINATION SITE INDURATION (Felt hardness, like she's been stung by a bee) and PAIN IN EXTREMITY (arm painful) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
30 minutes after getting vaccine I experienced lightheadedness & ringing in ears.  The ringing in ears has NOT stopped since February 16, 2021 at 3 pm.
BLOOD PRESSURE DROPPED AT HOME TO 88/41 AND THEN 81/39.  AND SYMPTOMS AT HOME WERE EXCESSIVE SWEATING, NAUSEA, EXTREME FATIGUE (SAME EXACT SYMPTOMS OF MI 5 YEARS EARLIER) AT THE EMERGENCY ROOM, BP DROPPED TO 72/38 AND 59/35 2 HOURS LATER AND MOVED INTO TRAUMA UNIT .   BP RETURNED TO NORMAL SHORTLY THEREAFTER.
same symptoms; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (same symptoms) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (same symptoms). At the time of the report, VACCINATION COMPLICATION (same symptoms) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications information was reported. No treatment medications were provided.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments   This case was linked to US-MODERNATX, INC.-MOD-2021-054380 (Patient Link).
Body aches, chills, 101.2 fever, nausea, and migraine headache
approximately 15 min after injection I passed out while still at clinic. After passing out onto the ground I unconsciously had convulsions and lost control of my bladder. After regaining consciousness I spiked a fever and remained weak and delirious  for the next 24hrs.
Tested positive for Covid after receiving the first dose of the vaccine; Tested positive for Covid after receiving the first dose of the vaccine/she is very fatigued but that is from the Covid; This is a spontaneous report received from a contactable consumer (patient).   A 67-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EN6202), via an unspecified route of administration on 26Feb2021 at single dose for covid-19 immunization. Medical history included high Blood Pressure and high cholesterol. Concomitant medications included losartan at a dose of 50mg per day; takes 25mg in morning and 25mg in evening for blood pressure, rosuvastatin calcium (CRESTOR) at a dose of 5mg once a day for cholesterol. Both the concomitant medications started a few years ago. The patient received her first covid vaccine dose on 26Feb2021 and she was supposed to get her second dose on 26Mar2021 but she got sick with COVID on 21MAR2021 and tested positive for COVID on 22MAR2021 but she thought her symptoms were there before a little bit. The patient asking that if she can have her second dose of the covid vaccine after 42 days if she had Covid following her first dose. It was reported that she was told to be at home for ten days, no repeat test. Patient was very fatigued but that was from the COVID, not her vaccine, that was over a month ago. Patient declines to complete the supplemental form at this time; she states that she is getting tired and would like to be transferred at this time. At the time of this report event outcome was unknown.   Follow-up attempts are needed. Further information is expected.
Patient was going to Dr. as he had not been feeling well.  When we got there, he was covered in bruising and petechia.
Pre-existing tinnitus (which was at a manageable level) increased drastically.  Primary care physician had no answers. One trip to an urgent care and received a prescription for a steroid that did nothing.  Tinnitus has been a bigger problem than ever before in the months following vaccination.
Called and said that since getting the first vaccine yesterday, she has been having a tingling in her lip and then in the night she woke up with a terrible headache and also now she is coughing terribly. She also reported that she has swelling in both cheeks and vision changes.
Information has been received from a registered nurse concerning a 70 year old female with a history of xylocaine allergy, and a splenectomy after idiopathic thrombocytopenia, who in "mid June 2007" was vaccinated SC with a dose of Zostavax. Concomitant therapy included gemfibrozil, lisinopril (manufacturer unknown), Tricor, atenolol and aspirin. The patient was seen by the doctor on 25-JUN-2007 with a 4-5 day history of bruising. The doctor prescribed prednisone as treatment. Lab studies included blood work and platelet counts, results were not reported. The patient also received platelets on multiple occasions as an outpatient. The patient was diagnosed with idiopathic thrombocytopenia "17 days after vaccination." The patient saw a hematologist and an allergist. The patient recovered "about three weeks ago" on approximately 02-AUG-2007. No other information was provided. There was no product quality complaint involved. The reporter considered idiopathic thrombocytopenia to be serious, life threatening, and other important medical events. Additional information has been requested.
Information has been received from a consumer concerning her 6-week-old grandson with no medical history or allergies who on 03-Jan-2007 was vaccinated with the first dose of Rotateq. There was no concomitant therapy. On 03-JAN-2007, the patient developed diarrhea and vomiting. Unspecified medical attention was sought, but no laboratory/diagnostic test were performed. In January 2007, the patient recovered from the diarrhea and vomiting. No further information is available.
rash in the face 3 weeks after each dose of moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash in the face 3 weeks after each dose of moderna vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 016M20A) 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, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced RASH (rash in the face 3 weeks after each dose of moderna vaccine). At the time of the report, RASH (rash in the face 3 weeks after each dose of moderna vaccine) outcome was unknown.            No relevant concomitant medications were reported. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not applicable.
Starting with body aches, followed by chills & 100 degree fever. Nausea, vomiting,  & headache.  Each symptom lasting about 2 hours.  Then nausea, vomiting & headache cycled again.  Extreme fatigue and headache beginning 36 hours after injection.
It was discovered that patient received his first dose of Pfizer before his 12 th birthday due to mother falsifying her son's DOB. DOB given was different , than patient's actual DOB.  Pfizer #1 administered to an 11-year old.  This was discovered by data entry team when they were entering 2nd dose Pfizer which was administered on 9/4/21- patient  presented with mom for his 2nd dose of Pfizer on 9/4/21 at which time mom gave the false DOB at that visit as well.  However, the child was 12 years old at the time of his 2nd dose.  Therefore, per CDC guidelines, the 2nd dose was appropriate.  The 4-week interval had been observed.  Supervisor spoke with mom, who was still present with patient in the monitoring area at the time, and she admitted that she lied on her son's DOB because she was so afraid for her son and wanted him protected since school was starting and they masks may not be mandated in the school.
This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Hot Injection Site after Second vaccine) and VACCINATION SITE ERYTHEMA (Red Injection Site after Second vaccine) 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.   In June 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jun-2021, the patient experienced VACCINATION SITE WARMTH (Hot Injection Site after Second vaccine) and VACCINATION SITE ERYTHEMA (Red Injection Site after Second vaccine). At the time of the report, VACCINATION SITE WARMTH (Hot Injection Site after Second vaccine) and VACCINATION SITE ERYTHEMA (Red Injection Site after Second vaccine) outcome was unknown.            No relevant concomitant medication was reported. Treatment information was not provided.
Patient developed cellulitis at injection site day after administration on 10/5/13. Injection sight was red and swollen. Primary care physician started cephalexin 500 mg for 10 days. Condition resolved after antibiotic treatment.
Patients right elbow swelled starting 2 hours after injection. Swelling decreased by that evening.
Client became faint 5-7 min post administration of hep A, hep B and Td. He progressed to shock and being in and out of consciousness. Color was dusky, ashey, diaphoresis, BP 70/30, weak, thready pulse-911 called. Paramedics responded. Client went to MD.
Thrombocytopenia (transient) achey 99.3 degrees chills.
Rash / red raised swollen on face then rash had moved to arms, and back.
Normally exercise 3 days per  week, for 4 1/2 Hours. On Apr 14 started feeling very weak over entire body, and unable  to walk without holding on to something for support. Internal shakiness, mental confusion, dizziness, more frequent headaches. Has occurred at various times during the day, and evening every day. Unable to exercise since Apr 14.
Headache; Soreness at vaccine site; Fever; Myalgias; Mouth ulcers; This is a spontaneous report received from a contactable consumer, the patient. A 20-years-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration in left arm on18Mar2021, at 08:30 AM as a single dose for COVID-19 immunisation. Medical history included ADD and genetic inflammatory fever syndrome. It was reported that no allergies to medications, food or other products. Concomitant medications included FOCALIN and LEXAPRO. It was reported that, prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. It was reported that the patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. On 18Mar2021 at 14:00 the patient experienced mouth ulcers, headache, myalgia, fever and soreness at vaccination site. Therapeutic measures were taken as a result of mouth ulcers, headache, myalgia, fever and soreness at vaccination with mortin (MANUFACTURER UNKNOWN). The clinical outcome of the events mouth ulcers, headache, myalgia, fever and soreness at vaccination site was resolving.   Information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from an office manager concerning a female who was vaccinated with a dose of Gardasil.  Subsequently the patient fainted.  Unspecified medical attention was sought.  The patient was fine after a little while, recovered and went home.  The office manager reported that the office now lays down the patients while administering Gardasil and makes them stay there for at least 30 minutes.  This is one of several reports received from the same source.  Additional information has been requested.
A raised red patch showed up the evening of the injection.  It was also warm to the touch.  It was darker pink the next day.  By Saturday, it was not as hot nor as pink.  The area was about four inches wide and three inches tall.  Patient applied benadryl cream and ice packs
Information has been received from a nurse practitioner for VARIVAX (Merck), a Pregnancy Registry product, concerning a 19 year old female patient with no medical history or drug reactions/allergies who on 24-NOV-2011 was vaccinated with a dose of VARIVAX (Merck) (dose, route and lot # not reported) and a dose of Tdap (dose, route, lot # unspecified). Concomitant therapy included calcium carbonate and prenatal vitamins (unspecified). It was reported that 3 days after receiving the vaccines, on 27-NOV-2011, the patient learned that she was 5 weeks pregnant (LMP: 23-OCT-2011, EDD: 29-JUL-2012). Nurse practitioner reported that the patient was seen for the first prenatal check up on 17-JAN-2012 where it was confirmed that the patient was pregnant; a blood work was performed. The patient had been treated with prenatal vitamins. On 28-JAN-2016, a call was placed to the office, receptionist stated that the nurse practitioner was no longer working in the office, hence no further information is available. Additional information is not expected as all correspondence are received. Narrative has been updated.
Subsequent to receiving vax, the pts experienced a large knot at the injection site that remained for a while. No further information is available.
extreme cramping in middle lower back lasting less than an hour. Muscle aches all over in upper torso moderate headache , cold all over   .relieved with ibuprofin and tylenol every 6 hours .all ending about 24 hours later with a warm mild fever like sensation and 2 hours of sleep.
Pfizer-BioNTech COVID-19 Vaccine EUA: Patient reports fever, body aches, chills, headache, and chest pain one day after receiving the vaccination. Patient had COVID before (November2020) and reports "this felt very similar to one of my worst days with symptoms". Patient reports only persistent symptom was feeling more tired than usual. On 12/22/2020, patient noticed a rash on back and under arms.
Pt with h/o myasthenia gravis presents to ED with 3 week h/o worsening weakness. Unclear exact timing on onset relative to vaccine administration but appears to have been a few days later. During these 3 weeks, patient also diagnosed and treated for a UTI but patient had worsening of weakness leading to falls x2 a few days before presenting to hospital ED. On admission to hospital, pt diagnosed with myasthenic crisis treated initially with non-invasive mechanical ventilation and plasmapheresis. DDx included UTI with encephalopathy and confusion related to it.
Feeling sick, muscle soreness, chills, trembling and loss of muscular control, fever, headache, nausea, hyperglycemia, uncontrollable diarrhea, polyuria, insomnia. Event lasted 32 hours. Slept 16 hours of that time, interrupted 11 times due to polyuria and diarrhea. Lost 5 lbs. Have not felt this sick in at least 20 years - not for any bout of influenza, But it only lasted a day. Took no medication including ibuprofen or acetaminophen.  Completely recovered
4/15/03 Temp 103, noted mosquito bite like lesions on back of hand. 4/16/03 Continued fever, lesions fading, hands started swelling. 4/17/03 Increased swelling of hands; new onset swelling of ankles, knees, and neck. Pain in upper abdominal quadrants radiating to back. Abdominal fullness noted. Dark urine. Seem and treated for viral syndrome with fluids and Tylenol. 4/30/03 New onset SOB. Hospitalized. Treated with antibiotics, breathing treatments, and O2. Fever and swelling continued. Evidence of CHF. Pain now localized to LUQ, with normal LFTs, elevated LFT's. Negative for mono. Negative ANA. Symptoms gradually diminished over 3 week period. After rash on hands resolved, experienced peeling of skin on hands and elbows. Dyspnea at rest related to cardiomyopathy, improving. Hepatitis, unknown etiology, resolving. Acute onset illness/Lupus-type reaction temporally associated with multiple vaccinations. Follow up 01/27/05: Recovery status unknown, lost to follow up. Follow up 02/03/05: Recovery status unknown, lost to follow up.
Patient had flu shot in clinic 10/25/21 and was administered a second dose at living facility 11/3/21 due to poor communication from facility coordinator.
A few days after receiving my 3rd COVID booster, I started having itchy red bumps that looked like hives and would go away and come back on random parts of my body. My coworker and I received the booster on the same day, and we both broke out with similar bumps. It's been 9 months since the booster and I am still getting them.
Sudden and gradual loss of vision, overheating, chills, migrane-like headache, nausea, muscle weakness, lightheaded
I ended up with COVID; I ended up with COVID; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An elderly female patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in 2023 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; bnt162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (hospitalization, life threatening), COVID-19 (hospitalization, life threatening), outcome "unknown" and all described as "I ended up with COVID". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Last season she received the Pfizer vaccine and all the recommended boosters. Patient ended up with COVID & spent 6 weeks in the ICU. She nearly died. so this year she will try another vaccine. Reporter considered events was caused by suspect product. Seriousness criteria was life-threatening, Event(s) resulted in (or prolonged) hospitalization.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Left arm, Left deltoid area upper 2/3 4" x 3" area of redness, swelling and tenderness with induration and increased warmth with injection site and scratch mark 2mm x 1cm.
Information has been received from a pharmacist referring her daughter, a 20 year old female patient with sulfur allergy. There was no pertinent medical history. On unknown dates when the patient was a baby, she was vaccinated with 3 doses of series of RECOMBIVAX HB (dose and route unknown). There was no concomitant therapy. On 18-JAN-2016 the patient had titers drawn which showed "she was negative, she had nothing, no protection". The patient was seen by an unspecified physician. No treatment was given for the event. The outcome was unknown. This is one of the two cases received from the same reporter. Additional information has been requested.
Our certified tech picked up the wrong flu vaccine (Flubloq) that was intended for patient's mother and administered the Flubloq to pt. who is 17 years old.  Flublod is not currently indicated for anyone under under the ago of 18.  Spoke with pt.'s mom who stated pt. will be okay and she was close enough to 18.  I did tell mom to report any side effects pt. may have in the days ahead.  I did tell pt.'s mom we don't anticipate any issues but still to be aware for anything unusual.
Received a third dose of the vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXTRA DOSE ADMINISTERED (Received a third dose of the vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported.).   On 20-Mar-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Mar-2021, the patient experienced EXTRA DOSE ADMINISTERED (Received a third dose of the vaccine). On 20-Mar-2021, EXTRA DOSE ADMINISTERED (Received a third dose of the vaccine) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This report refers to a case of Extra dose administered for mRNA-1273 (Lot number: Unknown) with no associated AEs.; Sender's Comments: This report refers to a case of Extra dose administered for mRNA-1273 (Lot number: Unknown) with no associated AEs.
pt recv vax; devel cellulitis;pt's arm was sore,red & black & blue for days;was unable to sleep due to pain;was hosp;tx w/ amoxicillin & dph as needed;at time of rpt,was awaiting heart & liver transplant;addtl info has been requested;
really bad stomach pain; extreme flu symptoms; really bad headache; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (really bad stomach pain), INFLUENZA (extreme flu symptoms), HEADACHE (really bad headache) and NAUSEA (Nausea) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025D21A and 49EZ1A) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 20-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Oct-2021, the patient experienced ABDOMINAL PAIN UPPER (really bad stomach pain), INFLUENZA (extreme flu symptoms), HEADACHE (really bad headache) and NAUSEA (Nausea). At the time of the report, ABDOMINAL PAIN UPPER (really bad stomach pain), INFLUENZA (extreme flu symptoms), HEADACHE (really bad headache) and NAUSEA (Nausea) outcome was unknown.            No concomitant medication listed.   No treatment information provided.