chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID-19 vaccine on 12/17.  After waiting 15 minutes, she felt slight dizziness but thought it was a "little panic attack", as she reports being nervous prior to vaccination.  She was on the elevator with a nurse when the dizziness increased, she became sweaty and nearly passed out.  The nurse assisted, but she felt ok by the time they reached their floor.  She drove home and couldn't do anything but lay on the floor because the dizziness had increased and her right arm was swelling and hives on lips.  She called Employee Health, but didn't get an answer (after office hours) so she called the house supervisor, who told her to take Tylenol and benadryl.     She didn't take benadryl for fear of becoming more fatigued and she wouldn't be able to get help.  She had a sore throat and slight SOB.  She reports 100.1 fever for a short time and didn't feel well x 36 hours, general malaise, dizziness, swelling in rt arm and hand so bad that she couldn't bend her fingers.      She didn't seek medical treatment or evaluation other than calling the house supervisor.    hx of: Raynaud's and cold induced urticaria, but denies hx of allergic reactions to anything including vaccines or medications.  Denies any current medications.   EE was advised to see PCP for evaluation and do not receive 2nd dose.
Rash Narrative:  Rash appeared 7 days post-injection, on back of neck extending to front  Other Relevant History:
Swollen/painful lymph node in neck on left side (same side as injection); Swollen/painful lymph node in neck on left side (same side as injection); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administered in arm left, administration date 2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, single), for COVID-19 immunisation. The following information was reported: LYMPHADENOPATHY (non-serious), LYMPH NODE PAIN (non-serious) all with onset 2021, outcome "unknown" and all described as "Swollen/painful lymph node in neck on left side (same side as injection)".  Additional information: The symptoms occurred within 24 hours of receiving 2nd dose of vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Complaining of soreness X 2-3 days, post vax, noticed a rash that looks like red dots under the skin and approximately 1/4" below the injection site. Rash is approximately 1 1/2" long and was first noticed on Sunday morning. Rash is itchy and confined to just the one area. Denies rash at injection site or any other areas. Denies edema to arm, neck or face. Denies difficulty breathing or swelling or any wheezing or welts. No other complications.
Contracted Covid verified by two (2) PCR tests. Symptoms mild. Mostly sore throat/felt like I couldn't clear my throat. Did not have aches, pain or headache. Temp of 99 one day only. Minimal coughing. I've had worse colds/respiratory illnesses in the past.
Patient received her 2nd COVID vaccine on 4/22/21; patient was seen at Hospital on 5/3/21 for leg swelling and pain; patient seen at Hospital by NP on 5/6/21 for hospital follow up appointment with continued leg swelling and calf pain; patient was confirmed to have an acute DVT in her lower left leg  (patient does have a history of a prior unprovoked DVT more than 10 years ago)
Intermittent Tinnitus starting approximately 1 week after my 2nd dose if Moderna Covid-19 vaccine.
21 hours after injection, lethargy and tired.  Approximately 40 hours after injection, loss of motor function on left side, specifically, could not lift left leg to climb stairs, combined with soreness in left hip and shoulder.  Hip pain is mild to severe, and deep, mostly around the top of the femur.   Approximately 8 hours later had sharp, shooting pains deep in the left leg/.  Felt like it was in the femur, paint started at the top of the leg and shot down to the knee.  Pain duration approximately 1 second, with multiple, sporadic occurrences over the next several days.  Approximately 3.5 days after injection, numbness in left hand - small (pinky) finger and radiating along side of hand to wrist.  Loss of motor function on left side resolved after approximately 8 hours, pain in hip, pain in shoulder and shooting pain in leg and hand numbness continue.  Shooting pain is intermittent, shoulder pain is intermittent, hip pain and numbness in hand are constant.
This spontaneous report as received from a Registered Nurse refers to unspecified patients of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. Since 07-FEB-2015, unspecified patients were vaccinated with improperly stored (may have been exposed to temperatures outside of the recommended range) VARIVAX (Merck) (Lots # K008824, exp date 19-FEB-2016; K020760 exp date 31-OCT-2016; K15994, exp date 23-SEP-2016; L001327 exp date 13-JAN-2017) (dose, route, frequency and strength unspecified). No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of two reports received from the same reported(MARRS #1508USA003624). Additional information has been requested.
injection site area got red; injection site area got itchy; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (injection site area got red) and VACCINATION SITE PRURITUS (injection site area got itchy) in a 68-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 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (injection site area got red) and VACCINATION SITE PRURITUS (injection site area got itchy). At the time of the report, VACCINATION SITE ERYTHEMA (injection site area got red) and VACCINATION SITE PRURITUS (injection site area got itchy) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. Treatment details included Cortisone cream, Ice.
My menstrual cycle began six days after my vaccination and the cramping pain I experienced was more extreme than usual and lasted a solid 36 hours longer than usual. I was later informed that this has been an anecdotal side effect.
on 3/3/06 pt developed rash on chest, face, neck and back, arms. Eyes started swelling by evening so took to ER. Physician in ER dx'd as allergic to eggs, ordered Benadryl and Amoxil. 3/4 mom brought pt to our clinic for follow up. Rash remained. PA ordered Prednisone (Burst and taper) on 3/11/06.
This spontaneous report was received from a nurse and refers to unspecified number of patients of unknown age and gender. No information regarding the patients' medical history, concurrent conditions, drug reactions and allergies was reported. On 21-APR-2015, the patients were vaccinated with doses of RECOMBIVAX HB (dose, route of administration, anatomical location, lot# and expiration date were not reported), which were exposed to temperatures outside of the recommended range. No adverse events were reported. This is one of the several reports received from the same source. Additional information has been requested.
Headache. Nausea. Headache went away after first day. Nausea continues into Day 3.
PSA level had fallen; This spontaneous case was reported by a consumer and describes the occurrence of PROSTATIC SPECIFIC ANTIGEN DECREASED (PSA level had fallen) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     The patient's past medical history included TURP on 26-Jul-2019. Concurrent medical conditions included Enlarged prostate and Prostate cancer (non-aggressive mild form of Prostate Cancer).    On 12-Sep-2022, 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 20-Oct-2022, the patient experienced PROSTATIC SPECIFIC ANTIGEN DECREASED (PSA level had fallen). At the time of the report, PROSTATIC SPECIFIC ANTIGEN DECREASED (PSA level had fallen) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Oct-2022, Prostatic specific antigen: 2.83 ng/mL.         Patient received a TURP procedure to reduce an enlarged Prostate. Unfortunately cancerous tissue was identified incidentally to that procedure [Gleason 3+3]. Patient's PSA has slowly increased suggested a non-aggressive mild form of Prostate Cancer.  PSA results included: On 22-Jan-2020:1.4 Aug 2020: 2.3 April 2021: 2.3 Oct2021: 2.8 April 22: 3.49ng/ml.  Patient was expecting PSA level to have increased gradually after vaccine administration. Patient not receiving medication (such as Finasteride or Dutasteride) just periodic 6 monthly checks of PSA levels. Treatment drug was not reported.
mild allergic reaction after booster arm is swelling in a way it didn't for the other two; burned in arm when it went in; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (mild allergic reaction after booster arm is swelling in a way it didn't for the other two) and BURNING SENSATION (burned in arm when it went in) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032F21A, 019B21A and 019B21A) for COVID-19 vaccination.     The patient's past medical history included Anaphylaxis. Concurrent medical conditions included Asthma. Concomitant products included BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT) for Asthma, METHYLPHENIDATE HYDROCHLORIDE (CONCERTA), SERTRALINE HYDROCHLORIDE (ZOLOFT), LEVOTHYROXINE, SPIRONOLACTONE, LEVETIRACETAM (KEPRA), TRAZODONE, MONTELUKAST SODIUM (SINGULAIR), FAMOTIDINE (PEPCID [FAMOTIDINE]), CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), MELATONIN and SALBUTAMOL SULFATE (ALBUTEROL [SALBUTAMOL SULFATE]) for an unknown indication.   On 30-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Dec-2021, the patient experienced PERIPHERAL SWELLING (mild allergic reaction after booster arm is swelling in a way it didn't for the other two) and BURNING SENSATION (burned in arm when it went in). At the time of the report, PERIPHERAL SWELLING (mild allergic reaction after booster arm is swelling in a way it didn't for the other two) and BURNING SENSATION (burned in arm when it went in) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medication use was reported.   This case was linked to MOD-2021-406115, MOD-2021-406125 (Patient Link).
Fever, chills, 1 cm area of erythema at site of PCV 13 injection (on R leg), nodule at injection site, and behavioral changes consistent with fear/anxiety/post traumatic stress from being held down.
Site: Swelling at Injection Site-Medium, Additional Details: Patient came back to pharmacy 10 hours after vaccine administration complaining of a swollen injection site. Upon examination patient had moderate swelling from deltoid area down to the elbow.
she has a cold; seasonal allergies; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (she has a cold) and SEASONAL ALLERGY (seasonal allergies) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     Concurrent medical conditions included Meniere's disease and Seasonal allergy.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, the patient experienced NASOPHARYNGITIS (she has a cold) and SEASONAL ALLERGY (seasonal allergies). At the time of the report, NASOPHARYNGITIS (she has a cold) and SEASONAL ALLERGY (seasonal allergies) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant information use was not reported.  Treatment information was not provided.
Arm swollen at injection site on left arm between elbow and shoulder. Length 8 inches by 4 inches, hard, hot, extremely sensitive to touch.  Appeared red. Still painful and swollen 12/06/2012.
This spontaneous prospective pregnancy report as received from a physician refers to a female patient of unknown age. Information on medical history was not reported. On an unknown date the patient was vaccinated with GARDASIL (dose, strength, route, frequency, indication not reported). It was reported that the patient received GARDASIL, reported as HPV, early in pregnancy. The patient became pregnant on unknown date. The last menstrual period (LMP) and estimated date of delivery (EDD) was not known. The outcome of pregnancy was unknown. The outcome of received HPV early in pregnancy was unknown. Product Quality Complaint (PQC) was not involved. Additional information has been requested.
This case was reported by a nurse via sales rep and described the occurrence of anaphylactic reaction in a 17-year-old male patient who received BEXSERO. On 3rd June 2016, the patient received BEXSERO .5 ml. On 3rd June 2016, less than a day after receiving BEXSERO, the patient experienced anaphylactic reaction (serious criteria GSK medically significant and other: As per reporter), injection site swelling (serious criteria other: as per reporter), respiratory distress (serious criteria GSK medically significant and other: As per reporter), difficulty breathing (serious criteria other: as per reporter) and wheezing (serious criteria other: as per reporter). The patient was treated with EPIPEN and medication unknown (Nebulizer (Name Unknown)). On 5th June 2016, the outcome of the respiratory distress and wheezing were recovered/resolved. On an unknown date, the outcome of the anaphylactic reaction, injection site swelling and difficulty breathing were recovering/resolving. The reporter considered the anaphylactic reaction, injection site swelling, respiratory distress, difficulty breathing and wheezing to be related to BEXSERO. Additional details were received as follows: The patient experienced what appeared to be similar to a latex anaphylactic reaction. The patient experienced breathing issues, swelling of the arm. The patient was treated with an EPIPEN and was taken to the emergency room. Once the patient arrived at the emergency room he was administered an additional EPIPEN. The patient experienced respiratory distress like symptoms and he could not breathe. The patient also received breathing treatments via a nebulizer. On 5th June 2016, the patient's mother called the health care provider and reported that the patients wheezing had subsided and the swelling in the arm was reduced.
First of all, I am reporting an efficacy issue with the Shingles vaccine, as all links on the FDA and CDC websites for reporting to VAERS are not working. I have tried both and used different computers. There is also no link to report technical problems. I find this rather disconcerting. So.. problem #1: The real reason I am writing though is to add to the body of knowledge regarding after market efficacy of the vaccine for shingles. I received the vaccine in May of 2012 at the age of 60. Around January 10, 2013, I began to experience left sided chest pains and tingling sensations under my left breast, left side of my chest and up the left back shoulder blade. The skin felt sunburned or raw, but, there was no visible sign of anything. The chest pains were intermittently intense and felt like electrical charges. By Sunday the 13th, they intensified and were frequent. I mentioned it to my family and this resulted in an immediate trip to the local ER. They thought I might be having a heart attack; All of the appropriate tests were done to rule out MI, including EKG, extensive blood work, chest x-ray, monitoring of vitals, physical exam. All of these were negative for heart related issues. The attending physician in the ER suggested that perhaps I was in the early stages of developing shingles, as in some cases, people can experience pain that mimics heart attack. He told me to be aware and on the look out for a rash and to follow-up with my private physician. Eight days later, Monday Jan 21, I developed a small rash precisely in the location of the most palpable skin pain on my left side. It was a holiday -MLK Day-, so I was seen in the the walk-in clinic and was prescribed acyclovir 800 mg/5 times per day. I have completed 2 days worth of acyclovir and am just beginning to feel some improvement. It is interesting that I experienced anything because 1- I had the vaccine and 2- I take a daily dose of NEURONTIN for chronic sciatica. The combination of these 2 things, may have masked a potentially very severe infection, but, I still felt like I might be having a heart attack and incurred thousands of dollars of tests in the ER, a rash, and probably several weeks of pain and discomfort -2 weeks so far...no end in sight yet-.
got Fluzone yesterday and felt bad; Initial information received on 20-Oct-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves female patient of unknown age who got INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] yesterday and felt bad (feeling abnormal).  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.   Concomitant medications were unknown.  On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE [lot number not reported and expiration date unknown] via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient felt bad (feeling abnormal) (Unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  Final diagnosis was feeling abnormal.   Relevant laboratory data was not reported.  It was not reported if the patient received a corrective treatment.  The event outcome was  reported as Unknown.  There will be no information available on the batch number for this case.
I've had a migraine, almost consistently, for almost a month. No medicine is helping it.
rash, itching, h/a x 24 hrs/over body torso front & back;
Hives and rashes covering all surfaces of skin including palms and soles of feet. Intense Itching. Joint pain in hands and wrists swelling of skin around eyes and lower lip.  Topical benadryl and hydrocortisone not helpful. Urgent care administered steriod shot and RX for cream. Limited treatment because of breastfeeding newborn.
On or about 0845 am, RN administered Covid vaccine (2nd one for patient). Attempted administration with syringe (a Haiou, 1ml, 23g, 1'', Lot 20JC2, Exp: 10-17-25) resulted in needle going into patient's arm, but the 2 piece retractable distal needle and hub separated from the proximal tube part of the syringe resulting in COVID vaccine dose being lost. None of the 1st dose entered patient's arm. With needle and distal hub still fully immersed in patient's arm, RN removed it and held pressure on bleeding. RN informed patient that needle failed, to which pt stated he was "shocked," and felt an "electric" sensation when needle was inserted. Patient tolerated well. Bleeding abated. RN administered a 2nd dose of vaccine to the patient with no problems on the same LUE, more medial by about 2 inches than the first attempt. Bandage applied to both sites due to scant bleeding. Patient tolerated well, but showed no emotion. Pt complied with all instructions, and RN thanked patient for coming in.
Patient not sure on lot number above. On 12/15/2021 I felt like the flu basically and it lingered with me for a while. At least 5 days. I felt a little nauseous, tired. Injection site was sore. I also developed a bump on my arm (which happened during dose 1 and dose 2). On 12/23/2021 my symptoms got worse. I got congested and it accelerated.
Pt reported dizziness and "tunnel vision". Vitals: 102/57, 72, 16, 99% -- > 94/58, 73, 16, 99% Pt placed in Trendelenburg position.  Pt monitored, given juice and water.  Pt stable and released from vaccination site
huge rash which is itchy and swelling; huge rash which is itchy and swelling; Fever; Chills; Joint aches; Vertigo; Vomitting; Vision was messed up; Arm hurt so bad; A spontaneous report was received from a consumer who was a male patient, who received Moderna's COVID-19 Vaccine (mRNA-1273) and his arm hurt so bad, he had vertigo, vomiting, vision was messed up, fever, chills, joint aches and later developed huge itchy rash and swelling.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 30 Dec 2020, prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 (Lot number: unknown) for prophylaxis of COVID-19 infection.  Later that day (30 Dec 2020), the patient's arm badly hurt.   On 31 Dec 2020, he had vertigo, vomiting, and his vision was messed up.   The next day on 01 Jan 2021 he had fever, chills and joint aches.  On 02 Jan 2021, he developed a huge itchy rash and swelling.  No treatment information was reported.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events arm hurt so bad, vertigo, vomiting, vision messed up, fever, chills, joint aches, huge itchy rash and swelling were not reported.; Reporter's Comments: This case concerns a male subject (age and medical history not provided) who received Moderna's COVID-19 vaccine (unknown Lot #) and experienced  non-serious events of pain in extremity, vertigo, vomiting, vision was messed up, fever, chills, joint aches and later developed huge itchy rash and swelling.  The extremity pain event occurred on the same day after the  first dose of the vaccine administration, while vertigo, and vision problem occurred one day after the vaccine administration. Fever, chills, and joint aches occurred 2 days after, while itchy rash and swelling events occurred 3 days after vaccine administration. The treatment for the events and outcome were not provided. Based on temporal association between the use of the product and the start dates of the events, a causal relationship cannot be excluded
Fever, SORE ARM,CHILLS DAY 1-4 Narrative: