chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Info has been received from a physician concerning an 11 year old male who was vaccinated SC, with a 0.5ml dose of varicella virus vaccine live. The physician reported that on 10/19/05, the pt developed breakthrough chickenpox characterized by 45 lesions and a temperature. Unspecified medical attention was sought. On 11/16/05, the pt completely recovered from the breakthrough chickenpox after unspecified therapy. Additional info has been requested.
I went to my family doctor on 09/01/2022 and I noticed I was having trouble breathing, moving about. I had weight gain. During my physical he noticed my heart rate was out of sync. My heart valves were not following the sequence. Instead of all 4 chambers following in sequence, one chamber was not. My family doctor diagnosed me with A-Fib. The doctor sent me to a cardiologist. I met the cardiologist on 9/6/2022. The cardiologist put me on a regime of medications, and I have been on those medications since then. The medications the cardiologist put me on: XARELTO; valsartan; furosemide; carvedilol; amiodarone. To put my heart back into normal rhythm they need to shock my heart. At the end of October 2022, when I see my doctor, if I have lost sufficient weight, then they will do the shock to put my heart back into rhythm.
began w/hive-like rash @ site of inject 6PM; inject over the next several days devel erythema multiforme w/fever; treated w/antihistamines;
Severe pain in shoulder and weakness in arm. Got worse as the day went on and by 8:00 PM could not move my arm or hand at all.
ANEMIC; BRUISING ON LEFT SIDE OF STOMACH; BRUISING AT INJECTION SITE/LEFT THIGH; BRUISING AT INJECTION SITE/LEFT THIGH; VACCINE CAUSED PAIN IN INJECTION SITE; HEADACHE; This spontaneous case was reported by a consumer and describes the occurrence of ANAEMIA (ANEMIC), CONTUSION (BRUISING ON LEFT SIDE OF STOMACH), INJECTION SITE BRUISING (BRUISING AT INJECTION SITE/LEFT THIGH), CONTUSION (BRUISING AT INJECTION SITE/LEFT THIGH) and VACCINATION SITE PAIN (VACCINE CAUSED PAIN IN INJECTION SITE) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ulcerative colitis.    There was no reported medical history.  Concomitant products included GABAPENTIN, LOSARTAN POTASSIUM, ATENOLOL, VITAMIN C [ASCORBIC ACID], ISOSORBIDE, MONONITRATE D'ISOSORBIDE, HYDROCHLOROTHIAZID, IDE 196 and MESALAZINE (LIALDA) for an unknown indication.   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 and third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose every two weeks. On an unknown date, the patient experienced ANAEMIA (ANEMIC), CONTUSION (BRUISING ON LEFT SIDE OF STOMACH), INJECTION SITE BRUISING (BRUISING AT INJECTION SITE/LEFT THIGH), CONTUSION (BRUISING AT INJECTION SITE/LEFT THIGH), VACCINATION SITE PAIN (VACCINE CAUSED PAIN IN INJECTION SITE) and HEADACHE (HEADACHE). The patient was treated with CLOPIDOGREL at an unspecified dose and frequency. At the time of the report, ANAEMIA (ANEMIC) and VACCINATION SITE PAIN (VACCINE CAUSED PAIN IN INJECTION SITE) outcome was unknown and CONTUSION (BRUISING ON LEFT SIDE OF STOMACH), INJECTION SITE BRUISING (BRUISING AT INJECTION SITE/LEFT THIGH), CONTUSION (BRUISING AT INJECTION SITE/LEFT THIGH) and HEADACHE (HEADACHE) had resolved.            Concomitant medication Included: Probiotic (Bifidobacterium Bifidum;Bifidobacterium Lactis;Bifidobacterium Longum;Lactobacillus Acidophilus;Lactobacillus Rhamnosus)(Lactobacillus Acidophilus, Lactobacillus Rhamnosus, Bifidobacterium Lactis, Bifidobacterium Longum, Bifidobacterium Bifidum).  Humira was discontinued, dechallenge was unknown for events vaccine caused pain in injection site, anemic and rechallenge was not applicable, dechallenge was positive for events bruising on left side of stomach, bruising at injection site/left thigh and rechallenge was not done.  The reporter's causality for co-suspect Humira for the events of vaccine caused pain in injection site, anemic, bruising on left side of stomach, bruising at injection site/left thigh and headache was not provided.   Reporter did not allow further contact
Patient experience severe GI distress including nausea and vomitting, onset 36hours after food.
Hives all over body from the neck down; It started as a prickly rash that developed into hives overnight; Chills; Nausea; Muscle ache; Joint ache; Allergic reaction; This spontaneous case was reported by an other health care professional and describes the occurrence of URTICARIA (Hives all over body from the neck down), RASH (It started as a prickly rash that developed into hives overnight), CHILLS (Chills), NAUSEA (Nausea) and MYALGIA (Muscle ache) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 011L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Oct-2021, the patient experienced URTICARIA (Hives all over body from the neck down), RASH (It started as a prickly rash that developed into hives overnight), CHILLS (Chills), NAUSEA (Nausea), MYALGIA (Muscle ache), ARTHRALGIA (Joint ache) and HYPERSENSITIVITY (Allergic reaction). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of UNK dosage form and IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event, at a dose of UNK dosage form. At the time of the report, URTICARIA (Hives all over body from the neck down), RASH (It started as a prickly rash that developed into hives overnight), CHILLS (Chills), MYALGIA (Muscle ache), ARTHRALGIA (Joint ache) and HYPERSENSITIVITY (Allergic reaction) had not resolved and NAUSEA (Nausea) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication were provided by the reporter.
Moderna COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Moderna Vaccines on 2/5/2021 and 3/5/2021. Presented to ED on 8/13/21 via EMS from home due to shortness of breath. Patient was 93% on RA en route to ED and stable upon arrival. After arriving to ED, patient has SpO2 88% and was placed on supplemental O2. It was noticed patient may have had short run of ventricular tachycardia and patient went unresponsive with a pulse but agonal respirations. Patient was intubated in the ED on 8/13/21 and eventually extubated on 8/15/21. Patient received Rocephin, Decadron, remdesivir. During this time patient was in AKI. On 8/16/21, pt found to have HR in 20-30s and on 8/17 was  severely bradycardic.  Remdesivir was stopped. Pt was transitioned to comfort care and hospice Patient expired on 8/18/21.
30 days after Janssen Injection, patient felt ill, dizzy.  Noticed large quantity of small red blood dots on legs, thighs, lower extremities.  Small bruise on left hand and left elbow blossomed in to massive black and blue and brown bruise.  Patient went to Well Center on 8/28/2021.  Doctors immediately send patient to Emergency Center.  Dr. took blood test and determined that patient was in critical condition with blood platelet count below <3k where normal platelet count should be 150k to 400k.  Patient Emergency evacuated via Ambulance Hospital main facility bypassing Emergency room and going directly in to critical Care unit.  Dr. took another blood sample and verified Platelets and red blood cell counts extremely low.  A platelet IV was administered to prevent patient from crashing.  Patient moved to Critical Care Unit upstairs where teams of doctors started determining action plan for recovery and initial cause of incident.  Patient blood tested for COVID, came back negative and count was normal.  Dr.'s tested Kidneys, Liver, Spleen, lower abdomen for any irregularities and found none.  Then performed a Bone Marrow Needle biopsy with a MRI for needle placement.  Bone Marrow test came back Normal.  Patient stayed in hospital until 9/1/2021 with a platelet count of 159k.  Patient given 30 day pill supply of predniSone 20mg 3 times per day for 30 days.  Massive bruising of hands, elbow, legs. Looked like patient had been in car accident.
Very large, red hot & swollen spot at injection site. Blisters below left knee, multiple sites on left hip, leg, foot, and ankle very sensitive to the touch. Also under left arm pit sensitive to touch (unable to wear bra). Thigh muscle sore, hard to stand for more than a few minutes. Walking is difficult, leg feels very heavy.
I experienced a burning feeling inside my penis for about a week with frequent urinating. I had the weird feeling while I was urinating. This feeling ended in a sudden erectile dysfunction and total lack of sexual feeling. It didn't occur to me whether this could be related to the vaccination. I told my primary physician that I have had a problem with my sexual feeling. He suspected it could be related to stress. I visited also a Urologist who referred me to another Urologist that I am going to visit next week.  Recently I suspected that the vaccine could be a cause when I traced it back to the time this issue happened and I was vaccinated.
Fatigue, body aches, temperature sensitivity began 10 hours after injection.  Symptoms worsened  for the next 18 hours, including joint pain, fever, chills, difficulty sleeping, nausea, vomiting, and headache. Symptoms were effectively reduced with use of Tylenol, and all symptoms subsided by  the morning of 4/30/21 (48 hours after injection).
Per patient, events started after leaving the vaccine clinic.  "At around 12 noon, left eye began to swell. Both upper and lower eyelids became puffy and red and became worse overnight. The symptoms began to go away by the next day and there was no lasting effects. My eye remained open the whole time and I never lost vision. I did not take anything to counteract the swelling."
Onset 7/10 4 PM - itching, swollen, hot, red arm. Fever 100.6. Seen in ER on advice of pediatrician, no treatment, exam only. Mom giving Tylenol and Benadryl. 7/15 residual redness decreasing.
Within a few minutes of receiving vaccine, patient slumped to right with eyes open and head shook for a few second and then was alert and vomited x 1. Hadn't had any breakfast so gave juice and crackers and felt better. No postictal state noted.
Symptoms of fever and rash came on at about noon today or about 3 hours after his office visit.  He had a fever earlier up to 103 tympanic but use a cool washcloth on him and does not seem febrile now.  He is sleeping currently.  She texted me 2 pictures of a rash on his face trunk and left arm that look consistent with patchy urticaria.  I advised her to treat him with Benadryl liquid, 1 teaspoon which is 12.5 mg up to every 6 hours.  High-dose vitamin C recommended starting with 500 mg 4 times daily.  She can use her vitamin C capsules opened up into his food for now.  If he is not taking this well, buffered vitamin C powder should be obtained from health foods.  Vitamin D3 is to be increased to 4 drops or 4000 IUs/day for the next week.  Work on getting adequate fluids into him.  Fever can be treated if he is miserable and not tolerating it well.  She said currently he does not seem febrile.
Moderna COVID-19 Vaccine EUA Body aches, shiver and chills (12 hrs following injection and last about 6 hrs), tender skin and muscles to touch and temp, pain in low back and hips, rash (small bumps and red skin) in the low back and along right oblique, tenderness under right arm and right arm pit
presents to the ED complaining of feeling feverish (did not check) headache, loss of smell and taste (started yesterday) and lower back pain for the past 3 days. Pt states the back pain worsened tonight to the point he was unable to sit or sleep. He states he was vaccinated x2.
vertigo; dizzy; Numbness of the Arm; my fingers still have some tingling; I was feeling off; my left arm and fingers get numbness; This is a spontaneous report received from a contactable consumer (Patient). A 81-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection Batch/Lot Number: EN6206) via an unspecified route of administration, administered in Arm Left on 10Mar2021 18:00 at 0.3 ML single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced numbness of the arm, fingers still have some tingling on 11Mar2021, dizzy on 16Mar2021, vertigo on 18Mar2021, she was feeling off and patient left arm and fingers get numbness in Mar2021. It was reported that Caller states, I had the vaccine last Wednesday, Pfizer covid vaccine on the 10Mar2021 first dose, and on the 16th, I started feeling a little dizzy, yesterday and last night I had vertigo. Never had vertigo, but that is what I think, it sounds like it. I was feeling off. I also, from the day after the vaccine, my left arm and fingers get numbness during the day and night and my fingers still have some tingling. My daughter feels to long since the shot and is not related. Caller states that her daughter is on her back about calling, states she doesn't know if call handler can answer this but her daughter is pushing her to call before she sends her off. Caller states that she received the vaccine on 10Mar2021, so a week ago Wednesday and she just realized now the connection. She states she has numbness of her arm and tingling of her fingers, and she still has it. States that she didn't connect it before but now she is seeing it could be related. She states that a week later after that, she started having vertigo and dizziness. Caller states that her daughter wants her to make sure its related to the vaccine. Caller states that she has no temperature. Arm Numbness and Tingling Fingers AE: States it occurred one or two days after. She states she didn't even connect it, she thought she was laying on her arm or something. States that it is mainly at night when she is laying down. Dizziness and Vertigo AE: States it didn't occur until a week later and that is why her daughter thought it was too long after the shot to be related. Clarifies it was her first dose. States she is afraid now to get the second one on 31Mar2021. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Covid-19; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (Covid-19) and PAIN IN EXTREMITY (Sore arm) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-May-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 18-May-2021, the patient experienced SARS-COV-2 TEST POSITIVE (Covid-19). The patient was treated with IBUPROFEN (oral) at a dose of one tablet by mouth every 6 hours. On 16-May-2021, PAIN IN EXTREMITY (Sore arm) had resolved. At the time of the report, SARS-COV-2 TEST POSITIVE (Covid-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-May-2021, SARS-CoV-2 test: positive (Positive) Positive.     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.   No relevant concomitant medications were reported.  Patient was given a transfusion for Covid antibodies in a facility on 26 May 2021 and felt better after 24 hours of the transfusion.  Company comment: This case concerns a 52 year-old female patient with no reported history who experienced the unexpected event of SARS-CoV-2 test: positive. The event occurred approximately 6 days after the first dose of mRNA-1273. The rechallenge was not applicable as the event occurred after the first dose. The benefit-risk relationship of mRNA-1273 is not affected by this report. This case was downgraded for seriousness criteria.   This case was linked to MOD-2021-321059.; Sender's Comments: This case concerns a 52 year-old female patient with no reported history who experienced the unexpected event of SARS-CoV-2 test: positive. The event occurred approximately 6 days after the first dose of mRNA-1273. The rechallenge was not applicable as the event occurred after the first dose. The benefit-risk relationship of mRNA-1273 is not affected by this report. This case was downgraded for seriousness criteria.
Red blotches around his whole body; Looks like sunburn; shedding skin constantly; White blisters on body; Aches/ Pain; Rash/rash for 4 months; Fever; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (Red blotches around his whole body), SUNBURN (Looks like sunburn), SKIN EXFOLIATION (shedding skin constantly), BLISTER (White blisters on body) and PAIN (Aches/ Pain) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036A27A and 030L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included PRAVASTATIN, AMLODIPINE, VALSARTAN, MONTELUKAST, VITAMIN D3 and CENTRUM SILVER [ASCORBIC ACID;BETACAROTENE;BIOTIN;CALCIUM;CHROMIUM;COLECALCIFEROL;COPPER;FOLIC ACID;IODINE;IRON;LYCOPENE;MAGNESIUM;MANGANESE;NICOTINAMIDE;PANTOTHENIC ACID;PHOSPHORUS;PHYTOMENADIONE;POTASSIUM;PYRIDOXINE HYDROCHLORIDE;RETINOL;RIBOFLAVIN for an unknown indication.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, 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 MACULAR (Red blotches around his whole body), SUNBURN (Looks like sunburn), SKIN EXFOLIATION (shedding skin constantly), BLISTER (White blisters on body), PAIN (Aches/ Pain), RASH (Rash/rash for 4 months) and PYREXIA (Fever). The patient was treated with TRIAMCINOLONE at a dose of 1 dosage form; HALOBETASOL PROPIONATE at a dose of 1 dosage form; CYCLOSPORINE at a dose of 1 dosage form; METHOTREXATE SODIUM at a dose of 1 dosage form and FOLIC ACID at a dose of 1 dosage form. At the time of the report, RASH MACULAR (Red blotches around his whole body), SUNBURN (Looks like sunburn), SKIN EXFOLIATION (shedding skin constantly), BLISTER (White blisters on body), PAIN (Aches/ Pain), RASH (Rash/rash for 4 months) and PYREXIA (Fever) outcome was unknown.       This case was linked to MOD-2021-068887 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Follow up received on 25 May 2021 contains non-significant information : Updated contact information. On 28-Jun-2021: Follow-up received on28-jun-2021.updated events.
vaccine rundown her arm and didn't feel she got the full dose; arm soreness; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL UNDERDOSE (vaccine rundown her arm and didn't feel she got the full dose) and MYALGIA (arm soreness) 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 15-Apr-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 an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (vaccine rundown her arm and didn't feel she got the full dose) and MYALGIA (arm soreness). At the time of the report, ACCIDENTAL UNDERDOSE (vaccine rundown her arm and didn't feel she got the full dose) and MYALGIA (arm soreness) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was taken. No treatment medication was taken.
Large red area 5 days after getting the vaccine. There is still a pale pink area, which still hurts.
Unable to move or lay on arm without pain. Unable to sleep due to pain. unable to dress, lift objects without pain.
About 1.5 hrs after vaccinations, pt became irritable and then both legs began swelling, right slightly more than left. Swelling progressed to halfway down calves and up to waistline, also had redness. Had low grade fever, no welts. Next morning swelling and irritability resolved.
pt recv vax & approx 30min post vax pt devel a h/a;MD indicated that 8 other pt had similar exp (WAES97100696 through 97100703);
Itchy; Right arm feel slightly weaker; Soreness in the arm of injection; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itchy), MUSCULAR WEAKNESS (Right arm feel slightly weaker) and VACCINATION SITE PAIN (Soreness in the arm of injection) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included ERGOCALCIFEROL, RETINOL PALMITATE (MULTIVITAMINS [VITAMINS NOS]) for an unknown indication.    On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, the patient experienced PRURITUS (Itchy), MUSCULAR WEAKNESS (Right arm feel slightly weaker) and VACCINATION SITE PAIN (Soreness in the arm of injection). At the time of the report, PRURITUS (Itchy), MUSCULAR WEAKNESS (Right arm feel slightly weaker) and VACCINATION SITE PAIN (Soreness in the arm of injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       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.   Reporter did not allow further contact; 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.
Proquad was given to a patient older than 12 years of age. Patient has not presented with any complications. This dose was given to complete the 2 dose varicella series and as the first dose for the MMR series. MMR will be administered to the patient to restart the series and Varivax will be administered to the patient to complete the 2 dose series.