chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Redness at the injection site and red/red streak down the arm went away after 3 days; site was really red and sore; red, itching rash came back on her arm and lasted about 11 days; itching rash came back on her arm and lasted about 11 days; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE ERYTHEMA (Redness at the injection site and red/red streak down the arm went away after 3 days), VACCINATION SITE PAIN (site was really red and sore), VACCINATION SITE ERYTHEMA (red, itching rash came back on her arm and lasted about 11 days) and VACCINATION SITE PRURITUS (itching rash came back on her arm and lasted about 11 days) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (Redness at the injection site and red/red streak down the arm went away after 3 days), VACCINATION SITE PAIN (site was really red and sore), VACCINATION SITE ERYTHEMA (red, itching rash came back on her arm and lasted about 11 days) and VACCINATION SITE PRURITUS (itching rash came back on her arm and lasted about 11 days). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Vaccination site reaction, at an unspecified dose and frequency. On 20-Jan-2021, VACCINATION SITE ERYTHEMA (Redness at the injection site and red/red streak down the arm went away after 3 days) had resolved. On 28-Jan-2021, VACCINATION SITE ERYTHEMA (red, itching rash came back on her arm and lasted about 11 days) and VACCINATION SITE PRURITUS (itching rash came back on her arm and lasted about 11 days) had resolved. At the time of the report, VACCINATION SITE PAIN (site was really red and sore) 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 Medication not provided by the reporter.   This case was linked to MOD-2021-011101 (Parent-Child Link). This case was linked to MOD-2021-011101 (Patient Link).   See case MOD-2021-011101 for details regarding the child case.  Most recent FOLLOW-UP information incorporated above includes: On 10-Feb-2021: No specific follow-up information recorded.
Patient states that she tolerates pain well. She states the vaccine administration and first few days afterwards were fine and the injection site soreness was tolerable. A few weeks after the shot, the patient was driving and had a shooting pain down the vaccinated arm that caused her to have to pull over. She states the pain was the worst she's ever felt, but after a few minutes it resolved. However, it continues to come back and seems to be getting worse. She said it's more of a shooting pain that is only in that arm. It is periodic. PCP has ruled out any heart issues, which was of concern. The frequency of these episodes is getting worse and so is the pain. Patient has informed reporter that it did not start until that vaccine and that she has not had any other changes that would account for these episodes. She informed reporter and incident was reported. Patient also states she has an appointment for re-evaluation due to the worsening of symptoms. Upon her own research, she believes it to be SIRVA.
Extra menstrual cycle with heavy bleeding, cramping, and blod clots.  Lasted 7 days and then had another menstrual cycle a week later.  Had two heavy menstrual cycles within 2 weeks.
Swollen; Red; Body aches; Dry cough; Headache; Fatigue; Slight fever 99.9; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (Swollen), ERYTHEMA (Red), PAIN (Body aches), COUGH (Dry cough) and HEADACHE (Headache) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported.  Concomitant products included VITAMINS NOS for an unknown indication.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced PAIN (Body aches), COUGH (Dry cough), HEADACHE (Headache), FATIGUE (Fatigue) and PYREXIA (Slight fever 99.9). On 04-Feb-2021, the patient experienced SWELLING (Swollen) and ERYTHEMA (Red). On 04-Feb-2021, HEADACHE (Headache) had resolved. At the time of the report, SWELLING (Swollen), ERYTHEMA (Red), PAIN (Body aches), COUGH (Dry cough), FATIGUE (Fatigue) and PYREXIA (Slight fever 99.9) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant description included high blood pressure, and cholesterol.  Treatment medication was not provided.
Headache, Fever, Diarrhea,  Day #3 Bell's Palsy LEFT side Narrative: Dose #2, Day #1 5-6 hours after vaccine, head pounding, felt terrible, was sent to hospital/REC COVID tested. sent home fever, chills, body ache, diarrhea. Day #2 still sick, similar to Day #1, called out from work. Day #3 feeling better, noticed mouth did not move when tried to eat sandwich, looked in mirror LEFT side of face paralyzed; consulted with medical friend, went to Urgent Care, was dx with Bell's Palsy secondary to COVID vaccine, was given steroids (prednisone) 60 mgm for 7 days, then taper 10mg down until completed, eye drops, eye patch. Worked Day #5, off Day 6 and Day 7, Day #8 training in the morning, on Day #8 went to hospital c/o not sleeping well, still HA, stressed, hard to eat, LEFT facial pain, sensitive to touch, LEFT eye pain, still experiencing symptoms as of today (9/14). 9/27 appt with PCP (emp states allergic to acetaminophen, ibuprofen, aspirin, nuts, rocephin, naproxen - carries epi pen
Post vaccine day one: sore throat began. Eight: Fever to 100 degrees, nausea, chills, night sweats, body aches began. Fourteen: Vasculitis rash added to above, arms, legs, cough. Persisting 30 days from vaccination.
pt states feeling tired afternoon of 18OCT94; felt worse 19OCT94; t101, tiredness, achiness, hurting back of neck, sore throat afternoon of 19OCT94; felt much worse 21OCT94; MD felt sx related to vax;rt arm swollen ecchymotic, lost 20lbs;
Patient developed acute onset of hives on face and body and reported facial swelling and difficulty breathing approximately 8 days after receiving first Covid shot.  Stated this occurred approx. 11:40pm 3/26/21. Patient arrived at ER 1:10am on 3/27/21 where facial swelling and rash on perioral area, upper back & proximal arms was confirmed. He was given prednisone 60mg, diphenhydramine 50mg & famotidine 20mg. Home RXs for diphenhydramine 50mg po q6h prn, famotidine 20mg po bid & prednisone 40mg po qd provided. He was discharged at 02:48.  Patient now recovered but will not receive second dose of Covid vaccine. *NOTE: patient stated grandmother had similar reaction to Covid vaccination which occurred one week after shot.
about 6 hrs after vaccination hives on arms, very itchy, warm irritated skin on stomach. fatigued and felt lethargic next 11 days. 12 days later fever fever 101 for 30 hrs, extreme fatigue, GI disturbances. Afebrile now but still have other symptoms.
This literature marketed report has been received from authors of the published article. It was reported in a Letter to the Editor, referring to a 76 year old female patient. The patient's medical history included tick bites, and only a few months following her recovery form Lyme disease, she had her first reaction to meat started 45 minutes after eating barbecue. Since then she had had multiple reactions of varying severity, some of which started less than 1 hour after ingestion of red meat. On an unknown date in 2007, the patient was vaccinated with ZOSTAVAX for prophylaxis. Twenty minutes after receiving the vaccine, the patient experienced anaphylaxis. She went into cardiovascular collapse, requiring emergency treatment and an overnight hospital stay. In 2010, the patient had ImmunoCAP IgE results as below: Total IgE: 645 kU/L Alpha-gal (z5): less than 0.35 kU/L, negative Chicken (f83): 0.40 kU/L Turkey (f284): less than 0.35 kU/L Beef (f27): 0.44 kU/L Mutton (f88): less than 0.35 kU/L Cat dander (al): less than 0.35 kU/L Pork (f26): less than 0.35 kU/L, negative Fel d 2 (e220) (cat serum albumin): less than 0.35 kU/L, negative Gelatin (c74): 5.00 kU/L Bovine gelatin (z21): 26.8 kU/L, high Porcine gelatin (z22): 62.9 kU/L, high Fish gelatin (z23): less than 0.35 kU/L The outcome of the event was unknown. The reporter considered anaphylaxis to be related to ZOSTAVAX. Upon internal review, anaphylaxis was determined to be medically significant.
Left arm started getting irritated and then the irritation moved to her chest, breaking out in hives hours after the vaccination. Later on, the hives traveled towards her abdomen, forearms, and neck being itchy and irritable. She took a Benadryl approximately 6:00 pm and hives decreased slowly over time after taking medication.
feeling very fatigue.; This is a spontaneous report from a contactable other-HCP.  A 59-years-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: l3249), via an unspecified route of administration, administered in Left Arm on 26Jan2021 as 2nd single dose for covid-19 immunization. The patient medical history was not reported. Concomitant medication(s) included sitagliptin phosphate (JANUVIA [SITAGLIPTIN PHOSPHATE]); losartan (LOSARTAN). The patient previously took aspirin [acetylsalicylic acid] and experienced drug hypersensitivity, lisinopril and experienced drug hypersensitivity. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE , Solution injection, Lot number/Expiration date: Unknown) for covid-19 immunisation. The patient did not receive any other vaccine in four weeks. The patient did not had COVID prior vaccination and post vaccination, patient had not tested with covid 19.On an unspecified date the patient feeling very fatigue. No treatment received for the event. The outcome of event was recovering. Follow-Up (15-Apr-2021): Follow-up attempts are completed. No further information is expected.
Localized nodule. Fatigue and myalgias for 2 weeks with subjective fever. No hospitalizations. No oral lesions. No joint swelling.
swelling, pain, erythema at injection site and nearby lymph nodes developed within a few hours of injection; persisted for 40 hrs and now gradually improving
Patient stated headache started day after she received 2nd Moderna injection and has been reoccurring everyday since with increasing intensity.  C/o nausea, photophobia, dizziness if moving too fast.  MRI ordered, WNL referred to Neuro.
Pre-syncopal episode, no LOC after leaving clinic, in building lobby.  Per mother 5-10 minutes after receiving vaccines.  Mother called 911, taken to ED by paramedics for further evaluation.
Pt recv vax on 10/23/98; on 10/24/98 pt exp cellulitis on left thigh, fever (103); tx=Augmentin & Ceftriaxone.
Red rash on right arm around the site the vaccine was given occurring  7-8 days later. Slightly  itchy, no treatment. I saw a news item about ?Covid arm? and thought it might be that.
pt recv vax; small 1x1cm hard knot at site of inject; no redness or warmth of skin over "knot" rt thigh;
Initial case was retrieved from the scientific literature on 08 June 2012. The following is verbatim from the report: "A 50-year-old woman was administered a routine adult immunization booster of 0.5 ml (5 Lf units) tetanus toxoid into her left deltoid muscle. Within 72 h she developed an enlarged 6-cm left supraclavicular lymph node. Her primary-care physician suggested observation. At 4 weeks after the injection, the lymph node remained enlarged, but smaller. At 7 weeks after toxoid injection, the node was still palpable, but further decreased to 2.5 cm. Owing to its persistence, the patient underwent an excisional biopsy. The initial pathology review reported a small lymph node focally infiltrated by sheets of small-to-medium sized atypical lymphocytes, with histiocytic cells scattered uniformly within the atypical lymphoid infiltrate, Flow cytometry analysis was interpreted as an atypical T-cell population co-expressing CD4 and CD8. The report described these findings as consistent with a T-cell lymphoproliferative disorder, specifically T-cell prolymphocytic leukemia/lymphoma (T-PLL). A PET/CT scan revealed no definite scintigraphic evidence of fluorodeoxyglucose avid malignancy. The patient referred herself to our center for discussion of treatment options. On out evaluation, she was asymptomatic, specifically without B symptoms Her examination revealed no adenopathy or hepatosplenomegaly. Her white blood cell count was 7.9 x 103/mm3, hemoglobin was 13.9 gm/dl and platelet count was 291 x 103/mm3. Comprehensive metabolic panel and lactate dehydrogenase were entirely normal. A review of the patient's lymph node sections revealed a partial loss of architecture with marked peracortical zone expansion. The cells in that zone were monotonous and small with slightly irregular nuclear membranes, but had no prominent nucleoli. Scattered among these lymphocytes were band histiocytes with foamy cytoplasm. The original dot plot of the flow cytometry was requested for review. On re-examination, we suspected that the CD8 expressed in T lymphocytes were somewhat brighter than normal and very dimly, probably nonspecifically, in the CD4 T cells. This gave the original analyst the erroneous impression of abnormal coexpression of CD4 and CD6 in the CD3+ T cells. We estimated the CD4:CD8 ratio to be approximately 10:1. We requested the blocks for immunohistochemistry. Indeed, we found that the expanded CD3+ T cells expressed CD4 only, with very few expressing CD8, and no double expression of CD4 and CD8. In addition, we found no less of CD5 expression and only some CD7 loss. TdT and CD34 stains were negative. Our diagnosis was a 'pseudolymphomatous' florid proliferation of CD4 T cells in response to the tetanus toxoid immune stimulation, not lymphoma. Bone marrow biopsy revealed normal marrow cellularity (70-80%) with trilineage hematopoietic maturation and no abnormal cells. Flow cytometry of blood and bone marrow revealed no clonal B-cell or T-cell abnormalities. The CD4:CD8 ratio in the patient's blood was 3:1 and in the marrow 2.5:1. No double-expressing T cells were identified." Documents held by sender: None.
2021 Pfizer COVID19 Vaccinations - Jan 25, Feb 15 & booster on Oct 20 Adverse Events afterward: Heart palpitations while in bed:  Mar 3, Oct 14, Nov 2, 14, 25, Dec 7 Nov 10 - was rejected for local blood donation because blood pressure was 178/102.  (I donate frequently and have never been rejected due to HBP.  Made a doctor appointment for the next day.) After multiple doctor visits 11/21 thru 1/22, I have been diagnosed w/high blood pressure and AFib.  I am now on 5 heart medications, as follows:  Hydrochlorothiazide 12.5mg, Amlodipine 5mg, Metoprolol 25mg, Flecainide 50mg, Eliquis 5mg.
Approximately 3 hours after vaccinations were administered, child vomited excessively, eyes rolled back in head, he began to shiver/fever, and he passed out within minutes of the episode. This was not believed to be food-related as his entire family ate the same meal for dinner and no one else got sick. This is also not believed to be illness related as the child never vomited again or had diarrhea.
p/vax pt w/erythema, swelling & warm/hot area @ site;denies pain or discomfort;area approx 3" in diameter;
Left side of face began to swell, itch, and become red (rash like).  From the bottom of chin to cheek bone including lips. 24 hours after shot Face is red with itching and rash has spread to full length of back.
sore left arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore left arm) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20A and 039K20A) for COVID-19 vaccination.     Concomitant products included FEXOFENADINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDE (ALLEGRA-D 12 HOUR), MONTELUKAST SODIUM (SINGULAIR), FLUTICASONE PROPIONATE (FLONASE ALLERGY RELIEF), AZELASTINE, PROGESTERONE and CICLOSPORIN (RESTASIS) for an unknown indication.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Jan-2021, the patient experienced PAIN IN EXTREMITY (sore left arm). At the time of the report, PAIN IN EXTREMITY (sore left arm) had resolved. Not Provided      mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Treatment medications included Tylenol, and Excedrin.   This case was linked to US-MODERNATX, INC.-MOD-2021-026796 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-026796:2nd dose case
Right upper arm with redness, swelling & warm to touch  qcm in size Dx with cellulitis.
12-5-07 615 AM woke, went to bathroom fell on floor < 3 sec. Mom found him whole body shaking, very tense, lying on back, neck rigid, eyes rolled back. Mother states lasted < 5 sec. Child woke stating "I fell down" - no temp.
Excessive crying greater than 8 hours. Vomiting. Knots in legs.
Information has been received from a 62 year old female consumer via Pfizer (other manufacturer # 2016108223) concerning herself, who had breast cancer since 1999. Historical drug included OXYCONTIN for 18 year for back pain. She underwent a mastectomy in June 1999, then 4-5 surgeries after that to change her implant. Blood clot occurred after one of her reconstruction surgeries, when an implant had to be changed. In approximately 2004 (reported as 12 years ago), the patient underwent knee replacement. In November 2015, a nerve test showed nerve damage. On 04-JAN-2016, the patient had kidney issues and was hospitalized, the creatinine level was high at 7.7 (unit not provided). The patient and her siblings had no adverse event following prior vaccinations. On 05-JAN-2016 morning (time unspecified), while the patient was in the hospital, a nurse came in her room and asked if she wanted the pneumonia shot. The patient thought she was over 60 year old and was vaccinated with PNEUMOVAX 23 (lot #, dose and route unknown) probable in the right arm. On the same day the patient also concomitantly received the first dose of Tdap injection (manufacturer unknown) in stomach. There were no any other vaccinations within four weeks prior to date listed. Concomitant therapies included AGGRENOX for blood clot, MS CONTIN for back pain, LUNESTA for sleeping, FLEXERIL for muscle relaxer for back, VALSARTAN HCT  for blood pressure and gabapentin for nerve damage in right leg and omeprazole. On 07-JAN-2016, the patient discharged from the hospital. On 08-JAN-2016 or 09-JAN-2016, the patient started experiencing constant headaches like migraine, joint and muscle pain, coughing and sneezing. On approximately 11-FEB-2016 (reported as last Monday), the patient went to her doctor mentioned headaches. Headaches like migraines, joint and muscle pain were ongoing and worsened. Coughing and sneezing were persisting. The causality of the events and suspect vaccine was not provided. Additional information has been requested.
A non-serious spontaneous report of administration of expired product was received from a health professional concerning a eight-year-old female patient. Medical history of the patient includes that patient was involved in a study. Concomitant medications have not been reported for this patient. The patient received the expired FLUMIST on 04-Dec-2010. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved.
fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever) and CHILLS (chills) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045A21A and 025A21A) 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 dosage form. On 22-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2021, the patient experienced PYREXIA (fever) and CHILLS (chills). At the time of the report, PYREXIA (fever) and CHILLS (chills) had resolved.            After the second dose of the vaccine she had fever and chills which lasted about a day. On 29-Oct-2021, the patient received booster dose.  Concomitant medications were not reported. Treatment information was not reported.   This case was linked to MOD-2021-378182, MOD-2021-378201 (Patient Link).
Pt given injections around 11am on 7/12/05.  Pt states approximately 1 hour later he developed approximately 10 "red blotches" on trunk and legs.  States he also ran a fever that night.  Denied shortness of breath.  Pt reported this on 8/9/05.
9:40 am - Husband states patient has lip swelling and itching. 9:45 am - Patient states mouth and throat itching, lips swelling. Given sip of water - difficulty swallowing but denies difficulty breathing. Patient states she is allergic to multiple meds. 9:55 am - Itching in multiple places and repeatedly clearing throat with difficulty swallowing.  Lip swelling noted - patient now moved to a bed and 911 is called. 10:00 am - Fire medics arrive and patient assessed. Patient taken to hospital via ambulance.
lot of kids are getting vaccine as off-label use; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of OFF LABEL USE (lot of kids are getting vaccine as off-label use) 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) at an unspecified dose. On an unknown date, the patient experienced OFF LABEL USE (lot of kids are getting vaccine as off-label use). At the time of the report, OFF LABEL USE (lot of kids are getting vaccine as off-label use) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant medications were provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-101698 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-101698:
CHILLS WITH SEVERE TREMORS/CONVULSIONS .  EXTREME HEADACHE AND DEHYDRATION. DISORIENTATION. CONTINUED OCCASIONAL CHILLS
Extremely rapid heart rate. Dizziness nauseous loss of sight everything went dark like I was passing out. Not able to breathe  properly as heart rate was so fast and I had pain in my chest because of this. Body felt like it was burning up. Once heart rate decreased I had uncontrollable snakes throughout my whole body. Like spasms. My head felt like it had a lot of pressure inside. My heart rate exceeded 100 but not sure if exact number. Paramedic on site took it.
Shot given subcutaneously instead of intramuscularly.  Large redness, left upper arm.
Developed redness, skin warm to touch, skin tender to touch, and some itching on left arm at site of injection; onset approximately 44 hours after dose. Resolved without intervention within 48 hours
5 minutes after getting shot she felt hot and faint.  Also felt weak like she needed to lay down.
Red, raised, itchy, pain at injection site; occasional ibuprofen, no other treatment