chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Clinic visit 4/7/21:   "60 y.o. year-old male who presents for left calf pain, swelling, and bruising that began on 03/27/2021. Patient states that 2 days prior to symptom onset he received the Moderna COVID-19 vaccine. He did have symptoms of fever 102 F for approximately 24 hours. After the resolution of his fever he notice swelling of the leg with tenderness any line of bruising going down the medial aspect of his leg. He noticed more prominence of varicose veins of the left leg and began using a compression stocking. His varicose veins seem to worsen with sitting as well as tenderness, and improves with walking. He notes a tenderness over the upper calf. He denies any history of DVT/PE. He notes that two brothers sustained blood clots, one he believes was in varicose veins which were ultimately stripped and the other he is not sure of the exact nature of the clots. He is unaware of any hereditary clotting disorder in his family. He denies any shortness of breath, difficulties breathing, or chest pains."  He was sent home with aspirin 325mg daily. Hospital admission 4/11/21  " 60 year old male with no PMH comes in c/o LLE pain that originally started 2 weeks ago and intermittently getting worse. The pain started around the left calf and has moved its way up to his thigh/groin area. The pain is sharp, 7/10, worse when standing, slight improvement with aspirin. Pt denies tingling, numbness, CP, shob, N/V/D, blurry vision or weakness. Associated symptoms include erythematic rash around left inner thigh, tender to touch, and swelling of calf/thigh. He works with heavy machinery but is always sitting down 1-2 hours at a time. He does have family history of DVT/PE. He is not on any daily NSAIDs or other anticoagulation and denies smoking."  he was started on a heparin drip then transitioned to Eliquis and discharged the next day.
Severe (R) arm pain, radiating to fingers and to trapezius. Intermittent tingling in fingers with numb sensation, developing within 10 min of vaccine. No urticaria or other systemic sxs.
Pt admitted >2 weeks after second dose w/ PCR confirmed COVID-19.  Severe illness requiring hospitalization and ventilation.
Severe chills, high fever up to 105 degrees F, racing heart rate, fatigue, muscle aches.   Pregnancy due date October 2, 2021. 15 weeks pregnant at time of vaccination.  Contacted OB and was told fever should not cause problems with pregnancy.
Note: I had zero negative effects from the 1st vaccine.  After the 2nd dose, I experienced very large hives all over my body,  headache, (came and went quickly),photosensitivity, "pins and needles in my left hand,  redness in both hands, nausea,  and body aches which have persisted since getting the vaccine (4 days ago)
dispersed red spot that lasted for 2 days on her left arm.; patient had a temperature of 104 degrees Farenheight.The fever lasted for a day; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE ERYTHEMA (dispersed red spot that lasted for 2 days on her left arm.) and PYREXIA (patient had a temperature of 104 degrees Farenheight.The fever lasted for a day) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001M21A, 012F21A, 013L20A and 026L20A) for COVID-19 prophylaxis.     Patient had several surgeries.  The patient's past medical history included COVID-19 in March 2020, Back surgery and Knee surgery NOS.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Apr-2022, the patient experienced VACCINATION SITE ERYTHEMA (dispersed red spot that lasted for 2 days on her left arm.) and PYREXIA (patient had a temperature of 104 degrees Farenheight.The fever lasted for a day). In April 2022, VACCINATION SITE ERYTHEMA (dispersed red spot that lasted for 2 days on her left arm.) and PYREXIA (patient had a temperature of 104 degrees Farenheight.The fever lasted for a day) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Apr-2022, Body temperature: 104 degree Fahrenheit.         No concomitant medication was reported. The patient had received her Moderna Covid-19 vaccine primary series and two monovalent Moderna COVID-19 vaccine booster doses. It was reported that patient was on several medications and did not wish to discuss her medications. No treatment medication was reported.   This case was linked to MOD-2022-646120, MOD-2022-646131 (Patient Link).
Papulovesicular rash developed at injection site and antecubital area of same arm 2 days after Hep A #2 administered. Topical hydrocortisone and oral BENADRYL provided. Rash spread to trunk/face 6 days after injection, prednisone x 5 days provided.
red rash with dots; feels like throat was closing; arm soreness; muscle aches and pain; injection site strated to itch; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (injection site strated to itch), RASH ERYTHEMATOUS (red rash with dots), MYALGIA (arm soreness), MYALGIA (muscle aches and pain) and THROAT TIGHTNESS (feels like throat was closing) in a 5-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. B(unsure if8 or B)53E21A) for COVID-19 vaccination.     Concurrent medical conditions included Dust allergy (mildew, mold are also allergic), Multiple sclerosis, Dysplasia and GERD. Concomitant products included COLECALCIFEROL (VITAMIN D3), Vitamin B12 and POLYCARBOPHIL CALCIUM (FIBER) for an unknown indication.    On 11-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Sep-2021, the patient experienced MYALGIA (arm soreness) and MYALGIA (muscle aches and pain). In September 2021, the patient experienced VACCINATION SITE PRURITUS (injection site strated to itch). On 16-Sep-2021, the patient experienced THROAT TIGHTNESS (feels like throat was closing). On 18-Sep-2021, the patient experienced RASH ERYTHEMATOUS (red rash with dots). On 12-Sep-2021, MYALGIA (arm soreness) and MYALGIA (muscle aches and pain) had resolved. On 18-Sep-2021, RASH ERYTHEMATOUS (red rash with dots) had resolved. At the time of the report, VACCINATION SITE PRURITUS (injection site strated to itch) and THROAT TIGHTNESS (feels like throat was closing) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was unknown The  patient ate mushroom and immediately  started to itch. So with that incident, the doctor told  that  he could develop allergies later on as  his  body changes. With my autoimmune disorder, he thought  it will change his  body's response to certain foods."
All over itchiness, almost like an allergic reaction, that comes and goes throughout the day.
Client was in 30 minute observation room post receiving the Moderna COVID-19 vaccine. The observation staff, in the room reported the client stood and suddenly dropped to the floor losing consciousness  and experienced tonic- clonic type movements. The client hit his head on the carpeted floor when he fell and had an abrasion on the left side of his forehead. The impression was that a vasovagal event had occurred.
This case was reported by a nurse and described the occurrence of fever in a 10 month old male subject who was vaccinated with Pediarix for prophylaxis. No medical history, concurrent conditions or concurrent medications were reported. The subject was also vaccinated with Haemophilus influenzae type b and Infanrix. On 17 August 2006, the subject received the third dose of Pediarix. On 18 August 2006, the subject experienced fever and irritability. He was treated with Ibuprofen. At an unspecified time after vaccination with Pediarix, the subject experienced fever. At the time of reporting the outcome of the event was unspecified.
Per medical record, the patient complained of a productive coughing, difficult breathing, wheezing an chest pain. His discharge diagnosis was noted to be Saddle embolus of pulmonary artery.
4/15/15 Mother presents to the window with child for vaccines. On record, child has only had up to 6 month shots. Mother reports that was in another location. Mother reports that received vaccines here. Clinic was at this time they are at lunch, as they are an hour ahead. Later appt. scheduled to allow for time to get records. PC and spoke with staff at that clinic and will fax records and child appears UTD. Does need flu vaccine if not done this year. Records put into electronic records. 1/6/2016: PC from mother to report that "child's right arm became red and puffy last night". This morning the swelling/redness reaches from her armpit to elbow and covers the back and side of her forearm, but does not completely circle around the front. Temperature of 100.4 at 5:30pm last evening; gave TYLENOL at 6:00pm last evening. Child was "up and down last night and whiny during the night". Not using arm today and child says "it hurts" and attempts to rub up against things due to itching. Gave Ibuprofen at 8:00am today for discomfort. Temperature 100.2 at 10:49am today. Mother instructed to call Dr. today for followup. Encouraged to apply cool packs to arm for comfort and continued with TYLENOL/Ibuprofen per Dr.'s recommendations. Parent reports no previous problems associated with vaccine administration in the past. Parent v/u. PC to LPN with Dr. and apprised of situation and copy of consent faxed to Dr.'s office today so that they can see what vaccines were given and what sites. VAERS to be completed. 1/7/2016: PC to mother to check status of child. Child seen by NP with Dr. and reaction was noted as "allergic reaction" per mother. Child given BENADRYL and has had 3 doses since being evaluated. Parent continues to alternate TYLENOL and Ibuprofen. Low grade temp. persists today. Parent continues with cool compresses to affected right arm. Parent reports that redness and swelling had increased more last evening, but has "greatly improved this morning". Child even using her arm more today.
Dry mouth; Did not sleep much for two days after Vaccination; Experienced rapid heart beat; This spontaneous case was reported by a consumer and describes the occurrence of TACHYCARDIA (Experienced rapid heart beat), DRY MOUTH (Dry mouth) and SLEEP DISORDER (Did not sleep much for two days after Vaccination) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016M20A and 032MZ09) for COVID-19 vaccination.     Concomitant products included OMEPRAZOLE for Acid reflux (esophageal), VALSARTAN (DIOVAN) for Blood pressure high, ROSUVASTATIN CALCIUM (CRESTOR) for Cholesterol, GLIPIZIDE and METFORMIN for Diabetes, CLONAZEPAM for Sleep disorder, POTASSIUM and ACETYLSALICYLIC ACID (ASPIRINE) for an unknown indication.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Feb-2021, the patient experienced TACHYCARDIA (Experienced rapid heart beat). On an unknown date, the patient experienced DRY MOUTH (Dry mouth) and SLEEP DISORDER (Did not sleep much for two days after Vaccination). At the time of the report, TACHYCARDIA (Experienced rapid heart beat) was resolving and DRY MOUTH (Dry mouth) and SLEEP DISORDER (Did not sleep much for two days after Vaccination) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided by the reporter.  Company Comment: Based on the current available information and temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded   Most recent FOLLOW-UP information incorporated above includes: On 22-Jun-2021: Follow-up received on 22-JUN-2021 contains the information updated patient initials. On 23-Jul-2021: Significant Followup- 2nd dose information updated. New Events (Dry mouth and unable to sleep) were updated.
pt experienced migraine next day and chest pain 30 min after vaccine adm. reported to pharmacy 1/10/23
Fever Started 09/23/2005. Temperature up to 103.8. Decreased appetite. Had red spots that looked like pimples, some of them with pus and raised with white color. Never crusted over. Seen at Clinic white on vacation probably reaction to vaccine. Mom states resolved by 09/27/2005.
35 year old female complained of having a flare-up of  red spots, rash and itchiness on both left and right arm that had already started the day before.
Swollen lymph glands on left side of chest and under left arm.  Tenderness for approx. 6 days. Then no tenderness and swelling has gone down little by little.  Small hard lump and swelling still evident, left side of chest near sternum on 5-4-21.
190 patients (9 different lot numbers) received a vaccine past the beyond used by date; No Adverse Event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) 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) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown. Not Provided      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 EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date).    Case contains information regarding patient 53 out of 190 reported.  Concomitant products were not reported.  It was unknown whether patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Treatment medications were not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-704335 (Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704335:Master case
Erythema and edema of most of right thigh starting a little over 24 hours after injection. Went to urgent care about 48 hours after injection was given oral prednisone. Having improvement. mild edema of right thigh present to day. Minimal erythema
No adverse effects reported; An unknown number of unspecified patients have been administered doses of vaccines that were improperly stored; This spontaneous report was received from a physician referring to a 15 year old patient of unknown gender. Pertinent medical history or concurrent conditions were not reported.  On 17-MAY-2017, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot # M043731, expiration date 22-JUN-2019 (dosage information and route were not informed). Information regarding concomitant medication was not provided.  Additionally, it was reported that the lowest temperature was 32°F and the higher was 54°F for 70 hours. Data logger was not involved. No adverse effects were reported. There was no product quality complaint involved.  This is one case from several cases from the same reporter.
For about 5 days following - Flu like symptoms. Low grade fever. Muscle and joint aches. Night and morning sweats primarily. Headaches.
Child was mistakenly given a Dtap and a Pentacel. Child was supposed to get a Dtap and a Hib. Therefore child received 2 Dtap and an additional IPV.  Child has not had any adverse reactions to the vaccines. Pt mother has been contacted
she had an INR test performed on her and she had a level of 6.20, the professionals that performed the test in the Hospital advised her that she should be at a level of 2.3; This is a spontaneous report from a contactable consumer or other non-healthcare professional reported for herself (patient) via Medical information team. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 Vaccine, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 10Mar2021 as dose 1, single for covid-19 immunisation. The patient's Medical and concomitant medications were not reported. On an unspecified date on Mar2021, the patient had an INR test performed on her and she had a level of 6.20, the professionals that performed the test in the Hospital advised her that she should be at a level of 2.3, she wants to know if it is safe to receive the second dose of the vaccine considering these lab results, she is not sure if she experienced some type of reaction to the vaccine. The response included Response: When vaccinating Persons with Increased Bleeding Risk, providers often avoid giving intramuscular injections (not just this vaccine) or choose alternative routes because of the risk for hematoma formation after injections. The Pfizer-BioNTech COVID-19 Vaccine can only be administered as an intramuscular injection. As per PI, 4 CONTRAINDICATIONS, Revised: 25 February 2021, LAB-1457-6.0. No specific contraindications for patients with an INR level of 6. Referred to her HCP for additional information. The patient underwent lab tests and procedures which included INR test (international normalised ratio): 6.20 on an unspecified date on Mar2021. The outcome of the event was unknown.  Information on the lot/batch number has been requested  Follow-up attempts are completed. No further information is expected.
Case previously recorded as MA2009-4535. Case report received from a registered nurse, on 10 NOV 2009. 26-year-old female pregnant patient was vaccinated with and overdose of 1 mL of FLUVIRIN (batch no. 98468P1) i.m.. No adverse effect was reported. Reference no.:NA09-007809. Follow up report received on 26 Apr 2010: There was an twice attempt to contact reporter, but no response received so far. Therefore the case was closed with a consideration as a lost of follow up.
Adverse reaction was only to pneumococcal vaccine.  Swelling was excessive and covered approximately a 4 inch length in muscle area above elbow.  Redness was excessive and covered the entire swollen area.  There was itching, soreness and pain in this area.  It took approximately 5 days before all symptoms cleared up.  I used hydrocortisone and Wal-iton recommended by pharmacist.  I had one pneumonia shot 5 years prior to this one with no reaction.  Follow up on 11/25/03: "I had no problem with the Influenza vaccine."
TEMPERATURE GOING UP TO 100.7; This spontaneous report received from a consumer concerned a 28 year old male. The patient's height, and weight were not reported. The patient's past medical history included possible covid-19 infection, and concurrent conditions included depression. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 043A21A, expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. Concomitant medications included mirtazapine for depression. On APR-2021, the subject experienced temperature going up to 100.7. Laboratory data included: Body temperature (NR: not provided) 100.7 F, 100.5 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from temperature going up to 100.7. This report was non-serious.
pt recvd vax & 11SEP92 w/in 2 hrs of vax devel nausea, indigestion, itching, wheals, urticaria all over; a cough & chest pain; the next day went to ER & was given DPH; face became swollen & itching cont; Seldane & Medrol dospak;
pt recv vax 16APR97 & 26APR97 pt devel a morbilliform rash on trunk & arms;pt was taken to MD office dx of the rash & subsequently recovered;
I had the booster on Tuesday and Tuesday evening I had the beginning of some reactions.  I had headache, aching all over{intense}, chills. sweats, tiredness, a slight cough, this lasted through the night  and all day Wednesday.  Last evening the symptoms began to ease some.  I still feel achy today {Thursday} but no where near as intense as before.  I wasn't sure if you needed this information.
Narrative:  68 y.o. male patient who received dose #1 of the Moderna COVID vaccine (Lot #029L20A, exp 7/13/21) on 1/29/21 and dose #2 of the Moderna COVID vaccine (Lot #011A21A exp 8/16/21) on 3/1/21. Patient had multiple comorbidities including: CHF, HTN, chest pain, dementia, COPD, Tobacco use, hypothyroidism, and alcohol use disorder. Patient was admitted to the hospital on 1/10/21 for respiratory failure/CHF exacerbation. He was then transferred to CLC 01/28/2021, hospital 01/31/2021 - 02/02/2021 (ASC rule out), then transitioned to inpatient hospice after discharge from hospital. Patient had an acute decline during hospital and passed in the CLC on 3/10/2021 @ 12:17. Reaction classified as severe as death occurred following vaccination.
Patient received 2nd dose of Pfizer Series on 01/06/2021. That following Monday 01/11/2021 the patient noted a very red, raised whelp on the arm that they had received the vaccination. They also  noted a center or core in the middle of the whelp. This type of reaction was not noted with the first vaccine and the area was not present prior to the vaccine per the patient's report.  Since the whelp persisted for numerous days the patient reached out the medical colleges for advice. Eventually in late January she sought the opinion of a dermatologist since the area of concern had not improved. The dermatologist was unsure if this reaction was caused by the vaccine but did  prescribe steroids to help with redness/swelling. Despite steroids the area did not improve. On a repeat visit to the dermatologist in late February a tissue sample of the whelp was taken and sent off for analysis. The analysis returned back as squamous cell carcinoma.  The patient reports that after this finding a 1.2CM area was considered to be squamous cell carcinoma. The dermatologist removed the carcinoma and repeat samples have returned back showing clear margins.  The patient does not report having a diagnosis of squamous cell carcinoma in the past.
On July 14, 2022 I thought I had a sinus infection and took a COVID-19 test and it was negative. I tested again two days and it was positive. My symptoms were runny nose, sinus headache. My doctor gave me a six pack of steroids and antibiotics. My symptoms have gotten better but have not went away.