chrisvoncsefalvay/vaers-outcomes huggingface dataset:
blacked out; can't remember much about it and don't know how she got on the floor; hard to get up; headache; still tired; stomach is real messed up; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (blacked out) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, the patient experienced ABDOMINAL DISCOMFORT (stomach is real messed up), HEADACHE (headache) and FATIGUE (still tired). On 22-Apr-2021, the patient experienced LOSS OF CONSCIOUSNESS (blacked out) (seriousness criterion medically significant), AMNESIA (can't remember much about it and don't know how she got on the floor) and DYSSTASIA (hard to get up). On 22-Apr-2021, LOSS OF CONSCIOUSNESS (blacked out) and DYSSTASIA (hard to get up) had resolved. At the time of the report, AMNESIA (can't remember much about it and don't know how she got on the floor) outcome was unknown, ABDOMINAL DISCOMFORT (stomach is real messed up) and FATIGUE (still tired) had not resolved and HEADACHE (headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not reported.  Treatment information was not provided.  Based on the information provided which includes a temporal association between the use of mRNA-1273 vaccine and onset of the reported events, a causal relationship cannot be excluded.  Headache and fatigue are consistent with the product safety profile; Sender's Comments: Based on the information provided which includes a temporal association between the use of mRNA-1273 vaccine and onset of the reported events, a causal relationship cannot be excluded.  Headache and fatigue are consistent with the product safety profile
Soreness in arm that started several hours (the following morning) later.  Fatigue Nausea from 7:00 pm to 11:00 pm the following day (within 48 hours)
Started menstruating earlier than anticipated, menstruating much heavier than usual with breakthrough bleeding while I slept last night, and menstrual cramping.
Fever, diarrhea, difficulty breathing. Being checked for pulmonary embolism after ER trip.
Employee came in the next morning for work and stated he was feeling nausea, chills, and body aches. He states he  had not eaten this date, and was given oral fluids and crackers. VS were obtained and found to be normal for the individual. He states this made him feel some better. After speaking with Agency, employee states he has previously had the Hep B vaccination with his prior job site. These were giving to him in May 2019, and June 2019. This was not disclosed to the center at the time the employee signed his consent for immunization. Employee left early  and Medical supervisor will follow up with employee by close of business today.
Watery diarrhea 6-8 times a day, ranging from orangey/yellow to green and mucousy. After 9 days I noticed a bit of red blood in diaper. Doctor tested poop and said he thinks she has a milk protein allergy. It's been 10 days since then and I've eliminated all dairy and she still has diarrhea all day long.
During the 15 minute observation period, the patient reported having an itchy throat, she got a glass of water from the facility but that did not resolve symptoms. Patient brought her symptom up to my attention, to which I asked for her to stay longer than the 15 minutes to observe if anything progressed, after she declining having an Epi-pen, per our company protocol.  I have called the pateint three times to follow up with no response back. Unclear of what occured after the patient left against my recommendation.
17 yo was administered Moderna, should have received Pfizer for dose 1.  No adverse events.
Patient called PCP 2 months after vaccine with complaints of shoulder pain, Throbbing pain, sometimes radiating down arm. Evaluated 3/2022 and provided steroid burst, PT referral, and referral to sports medicine. Currently being treated by sports medicine for bursitis.
About 10 minutes after shot I felt a bit flushed and light headed, then my face felt numb for a couple hours. I was then just tired on and off with a sore arm. On day 3 I started feeling congested with pulsing in my right ear followed by ringing tinnitus which continues to this day. I have taken Tylenol and ibuprofen a couple times, which doesn?t help much.  I am currently over the 7 day mark from first dose.
Headache- can be mild to severe but hasn't resolved since receiving the vaccine.  Patient has taken Tylenol but that does not seem to help.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. No information was provided regarding concomitant medications, concurrent conditions or medical history. In or about 2014, the patient was inoculated with ZOSTAVAX by a healthcare provider to obtain permanent prevention and protection against shingles and zoster-related injuries (dose, route, and lot # not provided). On an unknown date, the patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with ZOSTAVAX, and suffered serious physical, emotional, and economic damages as a result of patient's injuries. The patient was treated by a physician for shingles in or about 2016. The lawyer reported that as a direct and proximate result of the ZOSTAVAX, the patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death - aggravation of preexisting conditions and activation - of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. By the time of the report, the patient did not recover from shingles as the patient suffer for ongoing injuries. The outcome of vaccination failure was unknown. The events were considered to be related to ZOSTAVAX.
Diagnosed with Bradycardia; Dyspnea; Mobitz Type II A-V Block  Low heart rate 30s-40s; Currently monitoring with outcome of pacemaker implant
NOTED LA DELTOID REDNESS, EDEMA, NODULE 2" x 2"; AREA WARM TO TOUCH.  C/O LA PAIN AND BODY ACHES.  NOTED S/S ON 12-4-06.  S/S WORSEN ON 12-5-06; AT THIS TIME SHE NOTIFED MYSELF AND DR. PER DR., APPLY ICE AND OTC TYLENOL.  NOTED NO IMPROVEMENT ON 12-6-06.  DR.  NOTIFIED AND WILL ASSESS.
persistent nocturnal fever for 48hr;resolved spontaneously;max temp 105.8;
I just wanted to share a story about my husband. We live in the suburbs, and he is a 58 year old male in great condition. After getting the second dose of the vaccine, Pfizer, on June 13th, 2021 my husband started to feel different 5 days later. His heart will race and have pain in the middle of his chest, which felt like someone was sitting on him at the rib cage. Things started going downhill so, I took him to the ER on July 5th and they had to admit him because he had fluid in the heart and a small clog on the lungs. After staying in the hospital for a week, they told him he had Tuberculosis and Sarcoidosis. Also, he needed surgery to test the lymph nodes because he had 3 large ones. All of the tests came back negative and they're still ruling out TB, but it's dormant. Nothing makes sense to me and I may never have an answer. However, I do believe it was from the vaccine that he received. We are following up with many different doctors as well.
This spontaneous report as received from a clinical medical assistant to a patient of unknown age and gender. On 30-APR-2013, the patient was vaccinated with ZOSTAVAX 0.65 ml, intramuscular in deltoid (lot number and exportation date were not reported). No information was reported on medical history, drug reaction allergies or concomitant medications. No adverse reaction. The patient sought medical attention in office. Follow up information was received from the medical assistant concerning the male patient. It was reported that vaccine was given intramuscularly (IM) instead of subcutaneously (SQ). There was no adverse event. Additional information is not expected.
8 days after first pfizer dose covid vaccine injected into left arm, I found a small, pea-sized lump on my left collar bone. I have no history of illness or cancer and I will see my doctor who may order tests.
4 year old male developed significant cellulitis of L arm from deltoid to mid f/a requiring 24 hour admission for IV abx followed by Ed course of po Keflex.  Received from discharge summary and medical records swelling, redness and pain entered 12/30/03. msv
Patient broke out in rash the next morning and saw prescriber 2 days later for cortisone shot and Benadryl. Patient still has rash on his chest and ankles. Patient had received flu shots in the past, it was his first time receiving  Fluad.
About 7 days after Immunizations pt began having an extensive papular rash of the face, trunk, back, arms, and legs with some persistent irritability, fussiness, and clinginess since that time. Mild fever to 100.5 rectally as far as reported
Back ache; ache arm and legs; Ache neck; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Back ache), PAIN IN EXTREMITY (ache arm and legs), NECK PAIN (Ache neck) and FATIGUE (Fatigue) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042L20A and 025L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.  On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form.   On 09-Feb-2021, the patient experienced BACK PAIN (Back ache), PAIN IN EXTREMITY (ache arm and legs), NECK PAIN (Ache neck) and FATIGUE (Fatigue).   At the time of the report, BACK PAIN (Back ache), PAIN IN EXTREMITY (ache arm and legs), NECK PAIN (Ache neck) and FATIGUE (Fatigue) outcome was unknown.      Treatment details included warming pad. Concomitant product use was not provided by the reporter.; 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.
A terrible rash that traveled my entire body, starting from my neck, all the way down my legs, arms, stomach , breasts, and finally ending on my back. The rash lasted six months had to go to the doctor and was put on prednisone. It helped for a short time and then had to use Cortizone topicals to relieve itch until it went away . The rash was so bad. That bruising started happening. It was a very difficult six months.
I received a Tetnaus vaccine in the latter part of October, 2002 after stepping on a nail.  2 days later I completely lost my singing voice! My speaking voice was okay except when I tried to raise my pitch...It wouldn't go there!  I went to 2 different ENT Doctors and after complete testing  they told me nothing was wrong with my throat structurally (no nodules, tumors etc.)  the vocal folds were fuctioning properly.   I am a musician/singer so you can imagine how devastating this was to me.   The symptons are FINALLY subsiding.  I almost have all of my singing voice back!   I AM CONVINCED A NERVE IN MY THROAT WAS PARALYZED BY THE TETNAUS VACCINE
Local reaction with erythema and edema of RUE about 25cm. Pt denies any other symptoms. He also had myalgia of RUE.
NOTE: I had symptoms of SOB after 1st dose but always assumed it was COPD related. Extreme shortness of breath, A-Fib on occasion, with high heart rate and fluttering pounding. BPM is often noted in excess of 150, with many 173+ events recorded. When I learned I was experiencing  A Fib on occasion, I underwent a routine ablation procedure. During recovery, I "may have" developed pneumonia and C02 levels increased to 81%,. Intubation was considered a life-saving procedure. NOTE: This vent was after I had dose 1 and 2 but never thought it was heart-related due to my COPD. Also, I have had  general anesthesia on many w occasions and have never experienced any negative. side effects   Assuming my condition was COPD related, my emphasis was being treated by Dr. at Cancer, Hospital. On exam, my lungs were clear, my oxy sats were ok and my heart flutters were quick to recover. BP was within normal range upon exam.
Varicella rash, > 280 lesions (brother had breakthrough 2 weeks previous about 10 lesions
Case number PHEH2016US017740 is an initial spontaneous report received from a pharmacist on 13 Jul 2016. This report refers to an unknown demographics patient. Medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: unknown) at a dose of 0.5 ml on an unknown date. On an unspecified date, FLUVIRIN PFS went down to 29 degrees F for 3 days 15 hours and 14 minutes. The Vaccine was not frozen and had been administered. No patient/vaccine information available at this time. No adverse event was reported following this maladministration. Following an internal review done on 28 Jul 2016, for the data received on 13 Jul 2016: Significant case correction was performed. Changed the event coding inadvertent exposure to vaccine to incorrect product storage.
By 1 (14 hours post 2nd COVID moderna vaccine) in the morning my husband had a fever of 105.1, complete fatigue, pain, severe aches, chills
Grand Mal Convulsions, 105 degree fever, resulted in permanent severe brain damage.
Given MENACTRA, GARDASIL, Influenza Vaccines.  Approximately one minute after administration, adolescent, while sitting down, had syncopal episode, landed face first on floor braking glasses causing 2 lacerations to right eye between eyebrow & eyelid.
severe rash in trunk area, lower back, thighs; This is a spontaneous report received from a contactable other HCP (patient). A 42-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in Arm Left on 10Mar2021 17:30 (Batch/Lot Number: EN6204) as SINGLE DOSE for covid-19 immunization.  Medical history included obesity, gout, kidney stones and gastric sleeve bariatric surgery. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had no allergies to medications, food, or other products. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  The patient experienced severe rash in trunk area, lower back, thighs on 14Mar2021. The adverse event result in Emergency room/department or urgent care. No treatment received for the adverse event. The patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot ER2613) on 31Mar2021 at Arm Left as single dose for covid-19 immunisation. Since the vaccination, the patient has not been tested for COVID-19. The outcome was not recovered.    No follow-up attempts are needed. No further information is expected.
BRUISING/ KNOT AT INJECTION SITE/ WARMNESS AT INJECTION SITE/ TENDER TO THE TOUCH/ RED AT INJECTION SITE/ SWELLING; SWELLING WORSE; This spontaneous report received from a patient concerned a 59 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included sleep apnea, high cholesterol treated/controlled, seasonal allergies, sulfa drug allergy, alcohol use, and non-smoker, and other pre-existing medical conditions included the patient did not have any drug abuse, illicit drug use.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1805031 expiry: UNKNOWN) dose was not reported, administered on 27-MAR-2021 for prophylactic vaccination at right arm. No concomitant medications were reported. On 27-MAR-2021, the subject experienced bruising/ knot at injection site/ warmness at injection site/ tender to the touch/ red at injection site/ swelling. On 27-MAR-2021, the subject experienced swelling worse. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from bruising/ knot at injection site/ warmness at injection site/ tender to the touch/ red at injection site/ swelling, and had not recovered from swelling worse. This report was non-serious.
This spontaneous report was received from a other health professional (nurse) refers to a patient of unknown demographics. Patient's pertinent medical history and drug allergies were not reported. On 10-NOV-2014 the patient was inadvertently administered PROQUAD (Merck), .5 ml, subcutaneous (lot # and expiry date unknown) that had been improperly stored. No concomitant therapies were reported. No adverse effects were reported. No product quality complaint (PQC) was reported. Causality assessment was reported as not related to therapy with PROQUAD (Merck). This case is related to MARRS # 1411USA007073. Additional information has been requested.
Nausea started about 7:45 PM, followed by vomiting about 9:00 PM. Chills started about 8:00 PM. Took Zofran at 8:00 PM and again at 9:30 for the nausea and vomiting with no relief. Went to ER about 10:15 PM. Arrived in the emergency room with 166 heart rate and fever of 102.7, still vomiting. Admitted to hospital that night.
Site: Swelling at Injection Site-Medium, Systemic: Allergic: Difficulty Breathing-Medium
Developed a rash underneath both arms. Applied cortisone cream on it and it inflamed the area. Went to the Dr. and was told it was a Yeast infection under my arms, he prescribed cephalexin, fluconazole, and clotrimazole cream.
This spontaneous report as received from a 77 year old male patient refers to himself. The reporter stated that his 70 year old wife was vaccinated with ZOSTAVAX (lot#, dose, frequency and rout unspecified) in January 2007 and in April 2007 he broke out in a mild, flat rash on the right side of his back and shoulder. The patient was seen by a dermatologist in 2007 and it was confirmed as shingles. Treatment was some type of medication, unspecified. The couple state they did not know if the patient had chickenpox as a child. The reporter said that his wife  had a gut feeling it was not shingles.  The outcome of the event was reported as fully recovered on an unspecified date. Additional information is not expected as there was no consent to contact physician.
This spontaneous report was received from a male patient (age unknown) referring to himself. There was no information provided about the patient's concurrent conditions, medical history or concomitant medication. On 08-MAR-2017, the patient was vaccinated with a dose of ZOSTAVAX vials for prophylaxis (strength, dose, frequency, route of administration, anatomical location, indication, lot # and expiration date were not reported). The reporter stated that, on 13-MAR-2017, the joints of his left ring finger were very sore when he closed his hand (arthralgia). The outcome of the event and the relatedness between the event and ZOSTAVAX were not reported. Additional information has been requested.
Information has been received from a health professional concerning a 26 year old female who was vaccinated with Gardasil.  Subsequently the patient experienced swelling, a bump and itching at injection site after receiving the vaccine.  Subsequently, the patient recovered from swelling, a bump and itching at injection site.  The patient sought unspecified medical attention.  Additional information has been requested.
When I woke up at 0800AM, noticed with rashes on my back about 25%. I took Loratadine but not relieved. Went to ER at 05:00PM and they give Benadryl IV. Prednisone 60 mg tab & Pepcid 20 mg tab. After 2 Hours rashes resolved. Noticed with rashes also on both legs and adomen when I was in the ER.
I felt unwell/shaky that evening after receiving the flu vaccine. The next day, my vision was blurry, and the next day after that, I began having severe body aches, accompanied by occasional itching, shakiness, unsteadiness on my feet, and a numb tongue. My physician ordered some tests and said I showed high markers of inflammation. My doctor sent me to see a rheumatologist, who confirmed her diagnosis of polymyalgia rheumatica. As a treatment, I have been taking prednisone since November 2015. To this date, whenever I try to wean off the prednisone, the severe body pain returns.
I had left arm and shoulder pain. I had it through out the brachial nerve and down my hand. I had it around the injection site. I had neck pain as well. They did an EKG to rule out heart problems.  The prescribed me Ibuprofen to take. The Ibuprofen helped but I still had some pain. I just try to baby that arm.
Chest pain; Palpitations; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 09Oct2021 09:30 (Lot number: FF8839) at the age of 58 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Obesity" (unspecified if ongoing); "Degenerative disc disease" (unspecified if ongoing); "Prediabetes" (unspecified if ongoing); "Known allergies: Antibiotics +" (unspecified if ongoing). Concomitant medication(s) included: VIT D [COLECALCIFEROL]; EMERGEN-C. Vaccination history included: Bnt162b2 (dose 2, single, prev dose lot number= EW0151, prev dose administration time= 10:30AM, prev dose vaccine location= Left arm), administration date: 09Apr2021, when the patient was 58 years old, for COVID-19 Immunization; Bnt162b2 (dose 1, single, prev dose lot number= EN6199, prev dose administration time= 01:30 PM, prev dose vaccine location= Left arm), administration date: 12Mar2021, when the patient was 58 years old, for COVID-19 Immunization. The following information was reported: CHEST PAIN (non-serious) with onset 10Oct2021 05:30, outcome "not recovered", described as "Chest pain"; PALPITATIONS (non-serious) with onset 10Oct2021 05:30, outcome "not recovered", described as "Palpitations". The events "chest pain" and "palpitations" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of chest pain, palpitations.  Additional information: Report about Covid vaccine: Yes. Reporter type: Patient. Facility type Vaccine: Pharmacy or Drug Store. Other medications in two weeks: Vitamin d and Emergen-C. If Covid prior vaccination: No. If Covid tested post vaccination: No. Known allergies: Antibiotics +. If other vaccine in four weeks: No.  Follow-up attempts are completed. No further information is expected.