chrisvoncsefalvay/vaers-outcomes huggingface dataset:
had blood inside her right ear, a lot of blood, and is bleeding very easily/ more so than she usually does / noticed blood coming out of her ears / some of it was old dried blood and some was new; sore arm; achy; fatigue; chills; This spontaneous case was reported by a consumer and describes the occurrence of EAR HAEMORRHAGE (had blood inside her right ear, a lot of blood, and is bleeding very easily/ more so than she usually does / noticed blood coming out of her ears / some of it was old dried blood and some was new), PAIN IN EXTREMITY (sore arm), PAIN (achy), FATIGUE (fatigue) and CHILLS (chills) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025L20A, 012M20A and 025L20A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised, Lupus nephritis, Heart disease, unspecified and Systemic lupus erythematosus (Patient stated that - she has Systemic Lupus and has been on prednisone for 30 years). Concomitant products included PREDNISONE, MIRTAZAPINE, ROSUVASTATIN, WARFARIN and LISINOPRIL for an unknown indication.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced EAR HAEMORRHAGE (had blood inside her right ear, a lot of blood, and is bleeding very easily/ more so than she usually does / noticed blood coming out of her ears / some of it was old dried blood and some was new), PAIN IN EXTREMITY (sore arm), PAIN (achy), FATIGUE (fatigue) and CHILLS (chills). At the time of the report, EAR HAEMORRHAGE (had blood inside her right ear, a lot of blood, and is bleeding very easily/ more so than she usually does / noticed blood coming out of her ears / some of it was old dried blood and some was new), PAIN IN EXTREMITY (sore arm), PAIN (achy), FATIGUE (fatigue) and CHILLS (chills) outcome was unknown.            Patient states she got blood work done about 20 minutes ago to see if her clotting factor is off, she has not received her results yet.  No treatment medications provided.   This case was linked to MOD-2021-304463, MOD-2021-304558 (Patient Link).
Patient received 0.25mL of Moderna Covid-19 Vaccine, Bivalent; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of UNDERDOSE (Patient received 0.25mL of Moderna Covid-19 Vaccine, Bivalent) and NO ADVERSE EVENT (No adverse event) 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) .25 milliliter. On an unknown date, the patient experienced UNDERDOSE (Patient received 0.25mL of Moderna Covid-19 Vaccine, Bivalent) and NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (Patient received 0.25mL of Moderna Covid-19 Vaccine, Bivalent) 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 UNDERDOSE (Patient received 0.25mL of Moderna Covid-19 Vaccine, Bivalent).    No concomitant medications were reported.  No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 27-Dec-2022: Live follow-up document received includes no new information was added.
Hot flash Shortness of breath Dizziness  All within 2 minutes of injection, relieved on its own after resting for 15 minutes, remained extremely tired for the remainder of the day and the day following
patient became pale, starting seizing ~ 5 min after receiving the covid vaccine. her eyes were open, she was sitting up & shaking when RPh arrived. She was however unresponsive when RPh tried to talk to her. Seizure lasted ~ 2 min. Pt threw up at the end of it & then slowly came back.
30 minutes after injection started noticing numbness and tingling in left arm. It also went to left side of my face.  Felt like Novocain after a dentist visit. Also had high blood pressure. 232/100
10-12 pimples left deltoid around injection site. Itchy, painful. Scabbed over by 10/25/05.
suddenly hit with severe fatigue, myalgias, headache again with no other symptoms or explanation; Had severe fatigue; myalgias; headache/suddenly hit with severe fatigue, myalgias, headache again with no other symptoms or explanation; This is a spontaneous report from a contactable Physician (patient). This adult non-pregnant female patient (physician) reported for herself that she received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left (left arm) on 20Jan2021 (Lot Number: EJ1686) as dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient was not pregnant at time of vaccination. The patient did not have COVID prior vaccination. Historical Vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot Number unknown) as dose 1, single for COVID-19 immunisation. On an unspecified date in 2021, the patient had severe fatigue, myalgias, headache for about 36 hours after second dose. On 08Feb2021 15:00, 19 days after second dose the patient suddenly hit with severe fatigue, myalgias, headache again with no other symptoms or explanation. The patient underwent COVID test post vaccination (Nasal Swab Covid test) result: Negative on 08Feb2021. The patient did not receive any treatment for the events. Therapeutic measures were not taken as a result of events. The outcome of the events was unknown.   Follow-up (14May2021): Follow-up attempts completed. No further information expected.
Pt complaining of swelling around the eyes, tightening of the throat and difficulty breathing, approx. 20 minutes, post vax. Pt also had redness in front of neck area that extended to behind ear lobes. Treated with 50mg Benadryl IM, 4 puffs albuterol inhaler and Epinephrine.
16 hours after injection- (6 am) and lasting 10 hours  Nausea  Vomiting  Dry heaves Cold sweats  Headache Fatigue Muscle aches
acne; This spontaneous case was reported by a consumer and describes the occurrence of ACNE (acne) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced ACNE (acne). At the time of the report, ACNE (acne) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No laboratory details were  provided.  No treatment medications were reported.; 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.
Fever, aches, leading to chostochronditis (sudden onset - I had chest pains and went to ER.) They did an EKG, d-dimer, and chest CT. Eventually diagnosed chostochronditis
A day after vaccine, pt c/o feeling nauseous, dehydrated,  muscle aches/body aches
This spontaneous report was received from a nurse and refers to unspecified number of patients of unknown age and gender. There was no information about patients' pertinent medical histories, drug reactions or allergies provided. On an unknown date since 08-SEP-2015, the patients were vaccinated with improperly stored and expired 2 doses of GARDASIL (lot# K010574, expiration date 08-APR-2015, dose, anatomical location and route of vaccination were not reported). Additional information has been requested.
After 2 1/2 days of chills, starting feeling symptoms of peripheral neuropathy (crawling, tingling, pins & needles, goosebumps sensations.  All over body, at time very intense.  Some episodes of dizziness, not too frequent.  No fever.
Itching and pain near injection site. Redness and swelling extended to entire upper arm and down to elbow. Pt treated with Benadryl.
The day after the shot I experienced rib pain and shortness of breath which seemed to get better over the next few days.  On 5/29/21  I initially had pain in right side rib area and shortness of breath. Pain migrated to chest and became more severe. Shortness of breath also persisted.  I was unable to lie flat and tried to sleep sitting up in a chair, however the pain got so bad that I had to go to the emergency room where I was diagnosed with pericarditis and Afib.  I was put on IV and given Torodol pain meds. I was in hospital from around 4am Sunday May 30th until being discharged June 2. I have had follow-up visits with my primary care doctor and cardiologist and am currently on Metropolol. Dosage is 25mg two times daily and one baby aspirin once a day.  I was not in Afib on leaving the hospital but was back in Afib 6/17 at my cardiologist visit.
Pt states feeling itchiness a few hours after receiving flu vaccine and PPD testing. Today she reports welts, hives and itchiness. Denies breathing difficulty. States itchy throat after receiving. Pt. received vaccine 11/6/2012. Was referred to immediate care ctr.
A few days after my shot I started experiencing ringing in my head, with all sounds being amplified in my ears, with my left ear feeling clogged and with a constant "whooshing" sound. The sounds in my left ear became quickly overwhelming, with voices and rushing water, car engines, dryers, and even music unbearable. I can hear what sounds like a car engine running in my head, which gets more prevalent when lying down. For a few days voices, even my own, were doubled and metallic sounding. Currently voices are still "tinny". I have had pressure on the sides of my head near my ears, and have had a constant headache, a bit of nausea, and sweaty hands. I have lost weight, and sleep. Occasionally I hear a bell ring in my right ear, and if I turn my head to quickly, a "electric fan-like" sound appears in my hearing until I stop moving.
STARTED EVENING OF 6/13/07 WITH A "PIMPLY RASH" ACROSS SHOULDERS AND A 2 INCH IN DIAMETER CIRCLE ON CHEEK. NEXT MORNING SPREAD TO OTHER CHEEK AND DOWN NECK, BACK AND TORSO, "MACULAR AND PAPULAR IN APPEARANCE." THIRD DAY SPREAD TO LEGS. WOKE UP ON DAY FOUR AND RASH WAS GONE.
Received Pfizer vaccines on  1/20/21, 2/10/21 positive for COVID by PCR on 1/24/22 admitted to hospital 1/24/22-1/30/22 for bilateral hip pain, confusion, underlying AML Expired 1/30/22 d/t hypoxic respiratory failure, COVID-19 pneumonia
1st dose: 27Feb2021, 0.5mL intramuscular injection (documentation says 1mL administered); This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL OVERDOSE (1st dose: 27Feb2021, 0.5mL intramuscular injection (documentation says 1mL administered)) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 milliliter. On 27-Feb-2021, the patient experienced ACCIDENTAL OVERDOSE (1st dose: 27Feb2021, 0.5mL intramuscular injection (documentation says 1mL administered)). At the time of the report, ACCIDENTAL OVERDOSE (1st dose: 27Feb2021, 0.5mL intramuscular injection (documentation says 1mL administered)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant drug was reported. No treatment drug was reported.   This case was linked to MOD-2022-532408, MOD-2022-532418 (Patient Link).
Pt had a brain bleed on April 14th at approximately 2:00 in the afternoon and was emergency airlifted to Medical Facility. She stayed at hospital until April 21st. Pt is currently unable to read and recall information such as words, and her own birthday.
Information has been received from a medical assistant concerning an adult female who was vaccinated with a dose of MMR II on an unspecified date. The patient had titers drawn on an unspecified date. The patient did not know her immunization records and was negative for rubella only. No adverse effects noted. At the report time the outcome was unknown. This is one of several reports received from the same source. Additional information has been requested.
Patient said she noticed a large red area on her arm on 3-25-21 (almost a week after the vaccine).  She came to the pharmacy today (3-27-21) and showed me the large red area on her arm. She said it is red, tender, and itching.  She said is also warm to the touch. It is a very LARGE area of redness.  I told her to watch it and if it got worse to go the ER/DR.  It is a very large area. She has not seen a doctor about it yet.
40min p/vax pt was @ home, complained of severe h/a, nausea & blurred vision;laid down on couch & sx subsided on their own p/1-2hr;no problems since;
90 yr/o female with PMHx of AAA, CKD, GERD, PVD, dementia, who presents with speech impairment that was noted earlier today (2/25). Symptoms lasted about 15 minutes and completely resolved. She reports she had a similar episode a week ago. She reported associated generalized weakness and had some difficulty controlling her R arm on her initial episode. She denies headache or recent illness. Was recently admitted here for chest pain workup. Was treated conservatively. Has not had chest pain recently. She is on plavix.
Nausea, vomiting and diarrhea, body aches, temperature 100.1F, shaking chills and sweats. Treated with IV fluids, Phenergan suppositories, Motrin and Tylenol.
Arm sensitive to touch, painful, swelling. no redness. Primary Care Physician contacted by patient and told to take Tylenol and Ice area
VOMITING.  Pt had COVID vaccine yesterday morning. Pt was at dinner. When he started with bodyaches and headaches. This morning pt became weak, dizzy, shacky, n/v multiple time. Pt did not take any medicines.
I cannot even walk; weakness/I'm so weak; pain; numbness all over her body which had gotten worse day by day.; very tired; tingling all over her body; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP) from medical information team. The reporter is the patient. A 46-year-old female patient received bnt162b2 (COMIRNATY), administered in arm, administration date 01Jun2021 (Lot number: EW0181) at the age of 46 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose: Lot number: EW0182), administration date: 04May2021, when the patient was 46 years old, for covid-19 immunization.  The following information was reported: GAIT DISTURBANCE (non-serious) with onset 2021, outcome "unknown", described as "I cannot even walk"; ASTHENIA (non-serious) with onset 2021, outcome "not recovered", described as "weakness/I'm so weak"; PAIN (non-serious) with onset 2021, outcome "not recovered", described as "pain"; HYPOAESTHESIA (non-serious) with onset 2021, outcome "not recovered", described as "numbness all over her body which had gotten worse day by day"; FATIGUE (non-serious) with onset 2021, outcome "unknown", described as "very tired"; PARAESTHESIA (non-serious) with onset 2021, outcome "not recovered", described as "tingling all over her body". The events "i cannot even walk", "weakness/i'm so weak", "pain", "numbness all over her body which had gotten worse day by day.", "very tired" and "tingling all over her body" were evaluated at the physician office visit.  Additional information: It was reported that patient got one dose in left arm and one in the right arm, unsure which dose in which arm. Investigation assessment was not provided. The patient also stated that she had been to the doctors, everything was normal, cannot give her any medication they do not see anything wrong. Stated that she was just getting worse, reports weakness, pain, numbness and tingling all over her body, from her head to all over, states she has just been staying home, does not go take a walk, just getting worse, unable to work or walk really at this point. Patient stated she has been to the doctors, everything was normal, cannot give her any medication as they did not see anything wrong.  No follow-up attempts are possible. No further information is expected.
Severe rash 2 hours after getting the Pfizer-BioNTech booster around my waist line and inner groin areas. I have now been diagnosed with Urticaria. I have the rashes almost daily now. The rash is now migrating across my body. I now have the rash at my arm pit, buttocks, testicles, and penis in addition to my waist line and other areas. I take 2 benadryl and apply calamine lotion to the affected areas as required. The rash subsides after 1 hr after taking benadryl an applying calamine lotion. In January, my right lower lip blew up as well.
There was usual injection site and muscle soreness the day after.  That pretty much resolved and then about 3 days later an itchy rash around injection site developed and the area feels warm to touch.
Received the wrong 2nd dose of covid 19 vaccine 2 weeks early.  Should have received a second dose of Pfizer vaccine on 4/30/2021
I26.99 ACUTE PULMONARY EMBOLISM 3/31/2023 ATHEROSCLEROSIS OF AORTA
Enlarged lymph nodes, debilitating fatigue, muscle spasms, tinnitus, hair loss, heart burn, tachycardia, decreased function in activities of daily living, increased menstrual cycle pain and bleeding, brain fog, decreased concentration, skin rashes, vision changes, mood changes,
Information has been received from a physician and a medical assistant for the Pregnancy Registry for GARDASIL concerning a 16 year old female with anemia and a history of 0 pregnancies who in June 2007, was IM vaccinated with GARDASIL.  Medications taken during pregnancy included pre-natal vitamins (unspecified).  The patient became pregnant sometime during the vaccination series.  On 06-MAR-2008 the maternal serum alpha-fetoprotein test (MSAFP) was performed with the negative result.  A positive ultrasound for pregnancy was performed on 13-Mar-2008.  It is suspected that the patient's LMP is 23-Oct-2007.  The patient sought unspecified medical treatment with an office visit.  On 30-May-2008, the patient threatened premature labor.  On that same day, she was placed on therapy with terbutaline sulfate (5 mg Q4H until 36 weeks) and KEFLEX (500 MG QID).  On 10-JUL-2008 the patient delivered a normal female baby with apgar score 8/9.  There were no complications during labor/delivery.  There were no congenital anomalies abnormalities or complications.  Additional information is not expected.
Titer Drawn Showed No Immunity; Initial Report Received on 22-Mar-2023  A patient, and her pharmacist reported that she, a 47 year-old female (race and ethnicity not provided), received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and the patient had a titer drawn and it showed no immunity, the surface antibody quantitative test was negative.  No relevant medical history was reported.    No relevant concomitant medications were reported.    On 07-Nov-2022, the patient received the first dose of HEPLISAV-B (Lot # 939672, expiration date 14-May-2024 and NDC # 43528-003-05) to the left arm from a pharmacy.   On 07-Dec-2022, the patient received the second dose of HEPLISAV-B (Lot # 939672, expiration date 14-May-2024 and NDC # 43528-003-05) to the left arm from a pharmacy.   On 01-Mar-2023, 115 days after having received the first dose, and 85 days after receiving the second dose of HEPLISAV-B, the patient had a titer drawn and it showed no immunity. The surface antibody quantitative test was negative.   The patient reported that she experienced no other adverse side effects. The pharmacist was contacted who reported that the patient was going to have repeat lab work to confirm if the results were accurate.  No additional information was reported.   Company Comment: The company assessed the event as non-serious and immunologically confirmed based on dosing schedule and titer drawn.; Sender's Comments: The company assessed the event as non-serious and immunologically confirmed based on dosing schedule and titer drawn.
I developed A fib about a week after the first dose. I monitor my heart rate with my smart watch regularly and I noticed it fluctuating more often. I wait until after receiving the second dose to go to the doctor because I thought it was go back to normal. After doing an EKG I was diagnosed with Afib and put on Xarelto. I was then referred to a cardiologist. The cardiologist did more tests on my heart but they did not find anything in addition to Afib. They monitored me and I continued to take Xarelto until November 2021. Then, they put my heart into natural rhythm and it has continued to stay regular.
I arose on Saturday morning following the second COVID Moderna injection around 7:00 and was very cold in my legs and arms. By 9:00 I developed a headache, which I rarely experience. About 11:00 a.m. I began to run a slight fever. At 1:00 p.m. my fever was 104.9 degrees and remained this high throughout the afternoon, evening and night. I experienced chills, sweats and body ache throughout the 18 hour fever. Around 7:00 a.m. the fever broke and by 9:00 a.m. my temperature was just above normal. I slept the remainder of Saturday and did not feel fully well again until Tuesday. this is sicker than I have been from anything in over 30 years.
sore arm; little fatigue; This spontaneous case was reported by a pharmacist and describes the occurrence of PAIN IN EXTREMITY (sore arm) and FATIGUE (little fatigue) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Jan-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 (sore arm) and FATIGUE (little fatigue). At the time of the report, PAIN IN EXTREMITY (sore arm) and FATIGUE (little fatigue) 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 medication was provided.  No treatment information was provided.   This case was linked to MOD-2022-455277, MOD-2022-455278, MOD-2022-455207, MOD-2022-455209 (Patient Link).