chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Caller states she and her husband received their 2nd Pfizer vaccine dose in June, 90 days after first dose; dying septic; I had an echocardiogram and one of my cardiac arteries is 90% blocked and could this be the vaccine; had trouble with breathing worse after 2nddose of vaccine; This is a spontaneous report from a contactable consumer or other non-HCP (Patient herself).  A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration on Jun2021 as dose 2, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously took 1 dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: EN6200, Expiry date: 30Jun2021), dose 1 via an unspecified route of administration on Mar2021 as dose 1, single for covid-19 immunisation and experienced Covid and trouble breathing. The patient stated, she and her husband received their 2nd Pfizer vaccine dose in Jun, 90 days after first dose. She had trouble with breathing worse after 2nd dose of vaccine (In 2021). She had an echocardiogram and one of her cardiac arteries was 90% blocked (in 2021) and could this be the vaccine. She stated this was not blocked 1.5 yrs. ago. Her cardiologist said it was highly unusual to get blockage this soon. Could the vaccine cause blockage in her arteries. The patient wrote a letter to Pfizer asking if this could cause the blockage and no one wrote back. She wants answers. She would send another letter and if no one answers me this time, she would go to the Television (TV) and media and report Pfizer. She has been bounced between offices 2-3 times today. This was taking hours and is ridiculous. She said after her second COVID Vaccination she was dying septic (in 2021) of the (voice not clear) she doesn't know what that was. She says that one of her arteries was 90 percent blocked now in her heart and she was wanting to know if this vaccine could've had anything to do with it. She wanted to speak to someone. Her question when she first roll back way back then, could the shot cause COVID. They still haven't answered that question but now happened was she had been on wound healers (voice not clear) and have been having problems' (not clarified further hence not captured as event) and she went in for a catheterization the other day and they found that one of her arteries was 90 percent blocked and it was not blocked at all a year and a half ago. So, the doctors wondering why (incomplete sentence). The outcome of event had trouble with breathing worse after 2nddose of vaccine was not recovered and outcome of all other events was unknown.   Follow-up attempts are needed. Further information is requested.
Chest is sore. Right in the middle. Hurts to stretch or breathe deeply; This is a spontaneous report from a contactable Other HCP (patient). A 43-year-old female received BNT162B2 (BNT162B2, Solution for injection, Lot number: Not reported), via an unspecified route of administration in left arm on 05Feb2021 at 09:00 as first dose, single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not provided. The patient did not have COVID-19 prior to vaccination. On 05Feb2021 at 14:00 the patient experienced chest sore right in the middle. She informed that it hurts to stretch or breathe deeply. Outcome of the event was unknown.  Information on the lot/batch number has been requested.  Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
flu like symptoms; temperature and had 101°F; chills; Headache; Exhaused when temperature calm down; Completely dehydrated; Shaky; neck ache; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of DEHYDRATION (Completely dehydrated), PYREXIA (temperature and had 101°F), CHILLS (chills), HEADACHE (Headache) and PAIN IN EXTREMITY (Sore arm) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included MONTELUKAST for Allergy, LEVOTHYROXINE SODIUM (SYNTHROID) and LIOTHYRONINE SODIUM (CYTOMEL) for Thyroid disorder NOS, ATORVASTATIN CALCIUM (ATORVASTIN) and PANTOPRAZOLE for an unknown indication.    On 14-Jan-2021 at 11:15 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced DEHYDRATION (Completely dehydrated), PYREXIA (temperature and had 101°F), CHILLS (chills), HEADACHE (Headache), PAIN IN EXTREMITY (Sore arm), MUSCULOSKELETAL DISCOMFORT (neck ache), NERVOUSNESS (Shaky) and FATIGUE (Exhaused when temperature calm down). On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms). The patient was treated with PARACETAMOL (TYLENOL EXTRA STRENGTH) at a dose of 500 mg. On 15-Jan-2021, DEHYDRATION (Completely dehydrated), PYREXIA (temperature and had 101°F), CHILLS (chills), HEADACHE (Headache), MUSCULOSKELETAL DISCOMFORT (neck ache), NERVOUSNESS (Shaky) and FATIGUE (Exhaused when temperature calm down) had resolved. At the time of the report, PAIN IN EXTREMITY (Sore arm) and INFLUENZA LIKE ILLNESS (flu like symptoms) 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.
After the vaccine I had no problems, two months later when I got COVID-19 I had cough, congestion on my chest, diarrhea, fatigue, and a fever. Symptoms started on December 20th, on the 21st I had a home test and I tested positive, on the 22nd I called my doctor and started PAXLOVID, I took it for 5 days and I felt better. On the 29th my cough came back, and I was running a fever and then symptoms started to get better, on the 6th of January I became sick again with vomiting, diarrhea and a fever.
Arm soreness; Severe headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient (unknown if pregnant) received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown.), for COVID-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "Arm soreness"; HEADACHE (non-serious), outcome "recovered", described as "Severe headache". Therapeutic measures were taken as a result of pain in extremity, headache.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
On the 8th day after the shot, severe redness, minor swelling, and warmth to touch around injection site.  Circular in nature like a bullseye 6 to 8 cm
This spontaneous report was received from a medical assistant concerning a 14 years old female patient. The patient had none concomitant medication, pertinent medical history or drug reactions or allergies. On 31-OCT-2016, the patient was vaccinated intramuscularly with dose of GARDASIL (lot number: 014929, expiration date: 27-MAY-2017) (dose was not reported). On 31-OCT-2016 (reported as "few hours after vaccination"), the patient experienced fever, a chest pain and a near syncopal episode. The patient went to the emergency room and was given antibiotics. The patient was not admitted to the hospital and no laboratory diagnostics were performed. On approximately 02-NOV-2016 ("reported as "within 48 hours") the patient had recovered from the events. No product quality complaint (PQC) was involved. The causality between the events and the GARDASIL was not reported. Additional information has been requested.
The pt experienced chills that began a few hours post vax and continued 48 hours. Also redness at the injection site, about a 6" area, and warmth. The pt can use arm.
Dizziness, patient sat and lied on her back, she felt better and walked out of the pharmacy fine.
Pt received Varicella vaccine 2nd dose on 10/21/10. She present to Clinic on 11/01/10 with rash Dx: as chicken pox.
I am experiencing hives/rashes  initially starting from arm and then spreading across the body in a cycling style during the day. On the 15th-18 I took Benadryl at night due to the fact hives/rash was on both legs and armas and itching bad. It seemed to work. During the day at times it appears clear but by evening it slowly starts back up. I wen without Benadryl so as to not be addicted to see if it weens off. Still cylcling this morning when I woke. On both legs ,buttocks,and arms.I have discovered a hot shower actually helps in this situation. They seem to dissipate.
Pt c/o tongue tingling and 'molars' numbness as with first injection in which she reported to after sx started.  This injection, sx started earlier.  No soa, itching, throat tightness or distress. Pt numbness and tingling resolved and then returned with some throat numbness.  Pt remained without distress and after observation period opted to be dismissed and no er visit, called for ride, stated sx almost resolved at time of dismissal, no distress.  Dismissal vs- 117/83 bp 79 hr 98% sao2
9/3/2013 MMR and VZV given. 9/5/13-9/6-/13 Temp of 104.1, rash on neck and body thrush to tongue. Reported by Mom. 9/7/13 ER visit and treatment.
Pt's parent reports pt fainted while at band practice at school approx. 3 1/2 hrs after immunizations were given.
Prevnar vaccine was administered on 05/07/23 11:06 am. Patient stated arm became swollen and red on 05/08/23 08:30 pm. On Tuesday morning axillary area was also swollen. Patient came by the pharmacy on 5/10/23 at 11:00 am to show me his arm. The injection site was red and swollen. It was warm and hard to the touch. The Axillary area was also swollen.
Itchy rash 1/2 hour after vaccination with Flushot. Discharged from service. Benadryl  and Prednisone 10mg. Diagnosis-allergic to flu.
For the last 7 years my period has been very predictable. However, once I got the vaccine, I started spotting monthly. One time, the spotting was so bad that it turned into a period right after I had a period.
Fever, chills, and vomiting the evening of the vaccine administration.  Symptoms continued into the following evening.  Fever broke early morning of 3/8/2021
Pt was vaccinated 9/28/09 and pt developed redness, swelling and color at injection site 9/29/09. Today this leg is slightly more swollen.
One week post vax pt developed superficial vesicular rash with erythematous base of both upper extremities near sites of injection.
Patient called stated headache, fever, vomiting & diarrhea about 5 hrs after receiving shingles vaccine.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding medical history or concomitant medications. On or about 28-OCT-2016, the patient was administered ZOSTAVAX by a pharmacist at a pharmacy (dose, route, and lot # not provided). The patient's healthcare provider recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 12-FEB-2018, the patient was treated by a physician at a neurology service for shingles. She 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 the patient's injuries. As a direct and proximate result of ZOSTAVAX, the patient has and will continue to 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 including 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. The outcome of the events was not recovered. Causality assessment was related. Additional information has been requested.
Pt developed a blanchable maculopapular rash on his abdomen about 15-20 minutes after receiving the Flu vaccine. Pt appears well and denies any itchiness associated with the rash. Pt has not had any difficulty breathing or any other acute symptoms. Pt has been given Orapred and Benadryl. After observation for 40 minutes the Pt appeared stable and well without any respiratory distress, although the Pt's rash is increasing in size and is spreading to his arms. I will refer the Pt over to the ED for further evaluation.
Smallpox Vaccine given on 04/01/2003. About 12-14 hours later, devedloped diarrhoea and stomach cramps with diarrhoea and bloody stools. No other symptoms.
He kind of had like a little hives underneath; Rash; Achy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 5 year-old male patient received bnt162b2 (BNT162B2), administration date 02Dec2021 (Lot number: FK5618) at the age of 5 years as dose number unknown, single for covid-19 immunisation; influenza vaccine (FLU VACCINE VII), administration date 02Dec2021 (Batch/Lot number: unknown) as dose number unknown, single. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: URTICARIA (non-serious) with onset Dec2021, outcome "unknown", described as "He kind of had like a little hives underneath"; RASH (non-serious) with onset Dec2021, outcome "unknown", described as "Rash"; PAIN (non-serious) with onset Dec2021, outcome "unknown", described as "Achy". Therapeutic measures were not taken as a result of urticaria, rash, pain.  Additional info: Anatomical site of vaccination: Reporter stated, I believe it was on the left side and flu shot was on the right side. I think the flu shot was given at the bottom where he had rashes.  No follow-up attempts are possible. No further information is expected.
Patient called and stated she had weakness, nausea, swollen neck and jaw area, chest pressure and tightness with shortness of breath on the Friday evening post administration and finally left leg pain that radiates from hip area to knee on Tuesday post adminstration.   She has informed her primary care doctor of side effects as well as our pharmacy.
Pt. states that after receiving the 1st dose of Phizer 08/18/2021, started experiencing symptoms later that evening and clearing of the chest. Asthmatic known with congestion, states that clearing occurred and feeling better than before. No noted Primary visit.
3-4 days after the one dose shot i have been getting random welts of itchy/swelling over my body..most recent is very swollen lips. actively swollen at this moment.. Benadryl does not seem to help. 1 day after shot i had a 102.5 degree fever for 36 hours.
CHILLS; NAUSEA; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and it has been requested. No concomitant medications were reported.  On MAR-2021, the subject experienced chills. On MAR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and nausea on MAR-2021. This report was non-serious.
Chest infection; COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) and LOWER RESPIRATORY TRACT INFECTION (Chest infection) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product IBRUTINIB (IMBRUVICA) tablet for Small lymphocytic lymphoma (Nodal marginal zone B-cell lymphoma) (Working Formulation).    The patient's past medical history included Chemotherapy and Thoracic duct ligation (Procedure done to repair the ruptured thoracic duct in the lungs).   On 01-Oct-2018, the patient started IBRUTINIB (IMBRUVICA) (Oral) 420 milligram once a day. In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In August 2021, the patient experienced COVID-19 (COVID-19). On an unknown date, the patient experienced LOWER RESPIRATORY TRACT INFECTION (Chest infection). At the time of the report, COVID-19 (COVID-19) and LOWER RESPIRATORY TRACT INFECTION (Chest infection) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: (Positive) Positive.         No concomitant medications were reported. No treatment medications were reported. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
This spontaneous report was received from a pharmacist regarding a 25 year old female patient. Information on the concurrent condition, pertinent medical history and drug allergies were not reported. On an unknown date in 1994, the patient was vaccinated with VARIVAX (lot, expiry date, dose number, dose units, route and anatomical location were not reported) 1 dose. Other suspect therapies included M-M-R II vaccinated with 2 doses, one on an unknown date in 1994 and another on an unknown date in 2001. Concomitant medication were not reported. On an unknown date, patient presented to the pharmacy with "low serologic testing" (test results unspecified and unavailable), requesting to be re-vaccinated. The patient had been vaccinated in her native country (country unspecified). The outcome of viral test negative was unknown. No adverse effects reported. There were no Product Quality Complaint (PQC) involved. Relatedness of the event viral test negative with suspect therapies was not reported. Additional information has been requested.
12 hour flu-like symptoms: significant headache, significant body ache (I was unable to sleep or work), nausea, loss of appetite. No diarrhea or fever.
Transient period of facial numbness above upper lip lasting approx 5 minutes. Developed R arm and hand pain and weakness during night at 3am on 11/20/10.(arm that was injected) Pain and weakness concentrated between thumb and 1st finger affecting grasp and radiating up to mid-forearm. No numbness or tingling. Patient in Emergency department where I work had also presented with identical presentation within 48 hrs of her injection per report of MD that I work with. He shared this info with me upon assessing my situation. Did not have pt info to report/track.
Shots given 10AM 06/07/2005.  Mother noticed few raised red dots on stomach, the am of 06/08/2005.  Child here 06/09/2005 with red raised rash on torso, diaper area and face.  None noticed on arms and legs.  Temperature 99 8PM on 06/08/2005.  Gave Tylenol.  Temperature today is 96.  Rash fading 06/12/2005.
Vivid dreams; This spontaneous case was reported by a consumer and describes the occurrence of ABNORMAL DREAMS (Vivid dreams) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032M20A and 031L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient experienced ABNORMAL DREAMS (Vivid dreams). On 14-Mar-2021, ABNORMAL DREAMS (Vivid dreams) had resolved.            No concomitant medication details was reported. No treatment medication details was reported. Action taken with mRNA-1273 in response to the events was not Applicable.
Patient was recently admitted to the hospital for acute decompensated heart failure and discharged and then subsequent to home.   On 12/28/22, patient was brought to the ED by EMS as family was concerned about patient's progressive fatigue. She was also found to be hypoxic on room air to the 80s, and so EMS administered supplemental O2. Patient reported she has been feeling short of breath. Notably, she had tested positive for COVID approximately a week prior. Repeat COVID PCR test performed on that day also resulted positive. Patient was admitted 12/28/22 - 1/4/23 for acute hypoxic respiratory failure secondary to COVID-19 pneumonia with superimposed bacterial pneumonia and acute on chronic diastolic heart failure. She initially required 2L O2, but was able to be weaned to room air.
ACUTE STROKE DUE TO OCCLUSION OF RIGHT CEREBELLAR ARTERY ACUTE STROKE, UNSPECIFIED TYPE AND ARTERY
received one dose of Pfizer covid vaccine on  12/30/2020, then given dose of Moderna Covid Vaccine on 1/20/2021.  Starting a few hours after second vaccine severe joint aches and headache occurred.  Fatigue and severe muscle pain led to visits to Urgent care as well as an emergency department visit within a week of second vaccination.
Immediately after injection I felt a quick (like mild) electrical shock going from the injection site across the upper back. Then I felt some indigestion in my throat which passed quickly. Then I felt weak, like I was going to pass out. Seeing stars. Others told me my face was "very red" flushed. I was helped back to a chair. I felt alternating pain in the lower back from side to side just beneath my waist. I also had a mild tightness in my chest. This passed within a few minutes and pain wasn't severe. I continued to stay seated for about 10 minutes and was able to leave the pharmacy. I was accompanied by the husband and he took me home.  I experienced no symptoms while I was home nor in the time and days following.
Site: Itching at Injection Site-Mild, Site: Redness at Injection Site-Mild, Systemic: Allergic: Rash Generalized-Mild, Additional Details: Patient presented 6 days later stating he just started having a rash on his arm where the injection took place. It was his 3rd dose but previously had the pfizer vaccine for his first 2 doses