chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a physician via sales rep and described the occurrence of rash in a 74-year-old female patient who received SHINGRIX for prophylaxis. On 24th January 2019, the patient received the 1st dose of SHINGRIX .5 ml. In February 2019, 14 days after receiving SHINGRIX, the patient experienced rash and shingles. On an unknown date, the outcome of the rash and shingles were unknown. It was unknown if the reporter considered the rash and shingles to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported, but the patient was 74 years old at the time of reporting. The patient did not receive any concomitant medications. About 2 weeks after receiving SHINGRIX, the patient in the office experienced rash and was diagnosed with and treated for shingles.
per pt has persistent pain /soreness/ discomfort that is still occurring even thought she got vaccine 7-3-19.
hand tremors tingling in the throat Denies SOB, chest pain BP: 146/108 HR 70 Sp02: 97% Refused hospital transport, signed refusal form, seen and cleared by EMS
Ulcer inside lower right eyelid, hives, and diarrhea that lasted for one day. This all started at once. The hives are resolving. The ulcer is about 1mm in diameter. It does not cause pain. The patient is functional.
7-8 Days after 2nd dose of COVID Vaccine, the skin on my fingers started to peel like they would after a sunburn.  There was no prior rash.  I can only remember around 4 days after the vaccine, my fingers felt warm as if they had a sunburn, but I had no exposure to sun, UV, or any heat source that might explain the heat/peeling.  This did not occur to my wife, who received the same vaccine at the exact same times from the exact same batch from the exact same CVS.  The only side-effect she had was a swollen thumb on the hand belonging to the arm which received the vaccine.  This last form day 2 till about day 6 after the 2nd dose.  Did not occur during 1st dose, so we don't know if its related to the vaccine.  Again, we found no other cause for the potential swollen Thumb.
After midday of vaccine say I've non stop urinating. I've to go pee every 30 minutes or so. My mouth and lips are extremely dry. I wanted to report the symptoms because they seem peculiar.
On 10/11/19 I went for a physical and also got the flu shot and shingles shot. That night I awoke with excruciating pain in my hand. It felt like it would burst, my heart was beating in it, it was on fire and very painful. If I tried to move it I had to use my other hand because of the pain. The next day it still hurt but it was a Saturday so I didn?t contact my doctor. On Monday I called the doctor?s office and told my symptoms and then someone called me back and said it could be normal or could be a reaction but shouldn?t last long. Today it is 1 month since I have received those shots and I am not better. My right hand is in constant pain along with the soles of my feet. I cannot grasp with my hand. I can?t open a door, I can?t cut with a knife. Also my hips and ankles are sore. I am fatigued. Before this happened I was very healthy- where I worked I usually got about 10,000 steps. This has totally changed my life.
After 2nd shot my upper arm where I received shot was sore for a couple of days but that part of my body got okay but the same arm  (left) became sore in the area around my elbow about 5 or 6 days after the shot.  About two days later the right arm became very sore.  It has been around 6 months and they are still sore but better.  My right arm still feels weak some.  It doesnt bother me that much now but for a good while it was hard to lift over 4 or 5 pounds without it hurting some.  At times when someone would shak my hand with a firm handshake it would bother me.  It is not a constant pain but feels like my muscles are sore and at times it feels like my bones in the elbow area are sore.  I never experienced this until about 4 or 5 days after the 2nd shot.
herpes zoster keratitis; herpes simplex iritis and herpes zoster keratitis; bacterial infection; shingles; herpes simplex dendrites; Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. In or around 05-MAY-2015, the patient was inoculated with the zoster vaccine live (ZOSTAVAX) (lot number, dosage and route of administration not provided) as recommended for routine adult health maintenance for the prevention of shingles. Shortly after the receiving the vaccine, the patient suffered severe pain and soreness around the right eye and right eyelid along with popular vesicular rash on the right forehead. The patient was diagnosed with a bacterial infection and shingles/herpes zoster. After the initial outbreak, she started to experience multiple outbreaks around the eye and forehead along with blurred vision and was also diagnosed with herpes simplex dendrites, herpes simplex iritis and herpes zoster keratitis (herpes simplex, ophthalmic herpes simplex and herpes zoster keratitis). As a direct and proximate result, the patient suffered severe serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. In addition, incurred damages including medical expenses, the loss of accumulations, and other economic and non-economic damages. The outcome of the events was not recovered and the events were related to zoster vaccine live (ZOSTAVAX).   All the events were considered disabling events, as they caused permanent and incurable injuries.   Upon internal review, the events ophthalmic herpes zoster and ophthalmic herpes simplex were considered medically significant.
Itchy rash on neck and face still on neck and face, Severe headache on 9/3/2021, Fatigue- 4hours on 9/3/2021
PT HAD REDNESS ON THE FRONT OF THE VACCINATED ARM.  SHE ALSO DEVELOPED JOINT PAIN IN HER LEGS, HIPS, BACK, SHOULDERS AND BACK OF NECK AND HAD BODY ACHES THROUGHOUT.    SHE HAD HER FIRST SHOT IN OCTOBER 2019 AND HAD SOME NAUSEA AND SOME BODY ACHES BUT NOT TO THE EXTENT THAT SHE HAS HAD THIS TIME.
Pfizer 5/13/21, 6/3/21. Positive on 2/1/22
He got his vaccine, nothing until about midnight, and then his arm where he got the injection seemed very hot to the touch and it was aching, and he took some Tylenol.  After that he felt very dizzy, and after that he did have 3 different bouts of vomiting.  He has had other vaccines and has never had any reactions.  He was so exhausted and worn out, and did not want to eat which is unlike him.  She wanted to take him to the clinic and he did not want to go.  He has improved, this morning is the first day that he is feeling back to regular.  He did not have a fever during that time.   He is still a little worn out, but a whole lot better.   His appetite is just starting to come back.    This is quite a surprise that he had this type of reaction.  He has never been this sick.  His wife also had the vaccine, and she had nothing like he did and she was just feeling a little tired.  She had no arm pain, dizziness, no vomiting like he did.
Redness, warmth, swelling, around vaccine site started 48 hours after vaccine, cellulitis diagnosed. Treated with Augmentin.
Started with small rash/bumps on left hand approx 1 week after 1st vaccination. After 2nd dose approx 2-3 weeks, rash started to go up entire arm then went to left arm and chest. No itching.
missed the second dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (missed the second dose) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (missed the second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (missed the second dose) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment information was reported.
Less than 12 hours after receiving vaccine. Sx: fever, chills, abdominal bloating, lethargy. Sx lasted 24 hours.
Patient was sitting on exam table. MA gave VARIVAX, then HPV into her left arm. She immediately fainted. MA guided her down to lie on exam table, and after a couple of minutes, she woke up, sat up. Ate cookie, felt fine after approximately 20 minutes. Had not eaten anything today.
Client reports after approximately 1 week after received the 3rd Moderna Vaccine (1st Booster) he had right shoulder pain that radiated down his right arm to his fingers. The pain resolved then he started experiencing weakness and numbness in his right hand/fingers. Client is undergoing physical therapy now and has regained some strength but reports fingers are still much weaker than they were before this incident happend. Client reports his Neurologist believes this is a side effect from the COVID vaccine. Client also stated he has dont a lot of research and has come across a Study regarding this particular side effect.
After Immunization, patient developed Angioedema on her right periorbital area. Treatment: She was given an injection of Epinephrine 0.15 mL in her Left Thigh and Benadryl 12.5mg/5mL PO at 2:55pm.
Swelling above right collar bone. Noticed on evening of Apr 18 but could have been there earlier. Swelling was significant with a  moveable hard lump. Swelling has subsided some by April  22 but moveable lump is still there.
Pt recvd vax on 10AUG92 & 15AUG92 & exp a LOC & fell out of bed; seen in ER for a poss sz; EEG performed on 24AGU92 was abn; pt was treated w/Depakote; gradual dec in mental state; rt hand & rt arm became clumsy, unable to write & sz act;
feeling sick to my stomach ended up fainting onto bathroom floor; feeling sick to my stomach; arm felt mildly painful as injection went in; severe chills; fever; fatigue; restless sleep; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose at the age of 65-years-old via an unspecified route of administration on 08Mar2021 08:15 (lot number: EN6203) as single dose for covid-19 immunisation. Medical history included covid-19 (covid prior vaccination: yes) from 10Jan2021 to an unknown date. There were no known allergies. Concomitant medication included acetaminophen taken for an unspecified indication, start and stop date were not reported. The patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose at the age of 65-years-old, administered on the left arm on 15Feb2021 08:15 (lot number: EL9264) for covid-19 immunisation and experienced very painful injection site, chills, fever and fatigue. The patient reported that when she had her second vaccine on 08Mar2021, her arm felt mildly painful as injection went in, as though never healed from previous shot. This time, within 3 hours of vaccine, she began to feel fatigue, then began to experience chills and fever. She drank plenty of fluids, and took acetaminophen about 6 hrs after injection. In the evening her temp was up to 101.2 (her normal 97.2) and she took Acetaminophen at bedtime. Had very restless sleep, and at 5 AM on 09Mar2021, she got up feeling sick to her stomach ended up fainting onto bathroom floor. Luckily uninjured, and felt better upon "coming to". She was very fatigued rest of day, then normal next day. The patient underwent lab tests and procedures which included body temperature: 101.2 on 08Mar2021. No treatment was received for the events. The patient recovered from the events on an unspecified date.; Sender's Comments: Linked Report(s) :  Same reporter,patient,product/ 2nd dose;US-PFIZER INC-2021269674 Same reporter,patient,product/ 2nd dose
pt had 15-20second tonic/clonic sz p/vax;no past sz disorder-no apparent sequalae occurred 2min p/vax;
Patient was shaking and sweating. His muscles contracted in his hands and it appeared he might have been having a seizure. He came to and got very cold.
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 concurrent conditions, medical history, or concomitant medications. In 2010, a healthcare provider at a medical group administered ZOSTAVAX to the patient to obtain permanent prevention and protection against shingles and zoster-related injuries/conditions (dose, route, and lot # not provided). In 2017, the patient was treated by a healthcare provider for shingles. 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 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 has redness and swelling at the injection site, warm to touch and painful and seems to be increasing in size.
Patient recieved Janssen on 3/31 and then got Pfizer on 9/22
Initially, within 24 hours after receiving injection, I experienced mod. Body aches throughout my entire body, no fever, and was relieved by taking 2 Tylenol repeatedly for 12 hours.  Symptoms disappeared until day 8, at night, I experienced itching and devolved a welt, redness, heat, and raised area with enduration at the injection spot on my arm.  This continued through today, but it is slowly improving.  Still red, warm to touch, but not as raised, nor as endurated.
Information was received from a pharmacist via field representative concerning a female of unknown age. Information about concurrent condition, concomitant medication and medical history of the patient was unknown. On 14-NOV-2018, the patient received PNEUMOVAX 23 (strength, dose, route, lot# and expiration date were not reported) for prevention of pneumonia. On an unknown date in November 2018 (reported as an unspecified amount of time later), the patient developed an unspecified allergic reaction. On an unknown date in November 2018, the patient was admitted to the hospital in the intensive care unit for an unspecified reason (adverse event). The outcome of events was unknown. Information about treatment given for the event, lab diagnostics/studies was unknown. The causality assessment was not provided.
Dizzy, vomiting, passing out-( very deep sleep) occurred 6 days after vaccination. Vomiting ceased 4 hours later but dizziness continues to now. Dizziness when bending over.
7/5 woke with mild weakness and sensitivity to touch on left jaw shoulder upper arm and side: disappeared by evening 7/6 1:30 AM woke with tightness to throat. easier to breath sitting up. weakness and mild pain moved down chest to diaphram caused strain and  weakness in  breathing, throat clear, elevated respiration, went to emergency room at Hospital, Doctor seemed unfamiliar with side effects of vaccine sent me home, right side of diaphram slowly cleared 3:00 pm Sunday 7/7  1:00 AM left side of diaphram cleared breathing returned to normal bt a spot weakness ans d pain continued to move  around left side of upper body until about 4:00 AM. All clear by 6:30 AM. tired and sore for several days
Back ache, joint aches, weakness, shortness of breath, fast and irregular heart beat, fever, chills, head ache, light headedness, "out of body feeling", significant pain at injection site, nausea, loss of apatite, significant general malaise.
Swelling in throat, itching on face and scalp, severe headache, pain behind right eye, burning/tingling  in nose, light headed, and back pain. Ibuprofen and Benadryl taken. Still having symptoms...
Breakthrough case admission after 3 vaccines Moderna 3/15/21 Lot# 038A21A;  Moderna 4/12/21 Lot# 040B21A;  Moderna 12/10/21 Lot# 032H21A
Two weeks following vaccine varicella broke out with rash. No antibodies found in blood test taken four weeks later.
2nd dose of Meningococcal B  vaccine - first dose was Trumenba and second dose given was Bexsero
Approximately 8 months after receiving my vaccine I tested positive for COVID-19. Started having headache late afternoon and by the evening I was feeling worse and had scratchy throat. Went to the urgent care to be tested because I knew I had an exposure. The rapid test at urgent care was positive. Worst symptoms where couching, chest burning, and SOB. Symptoms proceeded for nearly a month. I took two rounds of steroids and two inhalers during the course of my illness. Still experience mild SOB and chest discomfort, with effort.
This spontaneous report as received from a medical assistant refers to 6 year old patient of an unknown gender. Information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapy was not reported. On 27-OCT-2016, the patient was vaccinated with improperly stored dose of VARIVAX (lot # M024675 with expiry date on 18-MAY-2018; dose and route of administration were not reported). The administered doses experienced a temperature excursion of 6.3 degrees Fahrenheit for 1 hour and 50 minutes, 6.6 degrees Fahrenheit for 1 hour and 40 minutes, 40.5 degrees Fahrenheit for 2 hours, 5.2 degrees Fahrenheit for 20 minutes and 6.3 degrees Fahrenheit for 1 hour and 50 minutes. Previous temperature excursion included 13.3 degrees Fahrenheit for 80 minutes and 9 degrees Fahrenheit for 420 minutes. Data logger was involved. No symptoms were reported. This is one of several cases received from the same reporter. Additional information is not expected as all relevant information has already been received. Sender's Comments: US-009507513-1610USA004609.
Vaccine administration error - patient requested Pfizer for 2nd booster (in those >50 yo) but was accidentally given Moderna 0.5ml instead at approximately 11:23am by the medical assistant vaccine administrator. Patient previously received Pfizer for her primary series (1/28/21 first dose, 2/17/21 second dose) and Pfizer for her first booster (10/29/21). The clinical pharmacist preparing the vaccines that day reached out to patient at approximately 1:30pm to notify patient of the administration error. Patient was informed that mixing of matching of Moderna & Pfizer brands is allowed per CDC recommendations. All questions and concerns from patient regarding vaccine boosters were answered by the clinical pharmacist.
Swelling, erythema , minimal tenderness, marked warmth, mild induration Left upper outer arm extending from just below shoulder to just below elbow on day after injection, increasing throughout the day. Seen around 3:40 after injection.
7/30/2007 Patient was in office and showed a 8" long reaction x 2" red and itchy area.
Started with pain in armpit.  In evening started to have chest pressure.  Next morning was sent to hospital for ultrasound.  Moved to ER told by doctor had a DVT. Placed on blood thinners.
After patient had received all of the vaccines she had fainted while being held by the social worker. She woke up within a minute of fainting and then was given apple juice and crackers to help get her feeling better. We also gave her an ice pack for the back of her neck. Patient was also very anxious to receive vaccines before we had even started.
affected my head and my ears; affected my head and my ears; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 omi xbb.1.5 (BNT162B2 OMI XBB.1.5), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: EAR DISCOMFORT (non-serious), HEAD DISCOMFORT (non-serious), outcome "unknown" and all described as "affected my head and my ears".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
body ache; muscle ache; pain; Headache; tiredness; fever; Feeling hot; sweaty; feeling clammy; This case was reported by a consumer via call center representative and described the occurrence of general body pain in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 12th March 2019 and had not adverse events). Concurrent medical conditions included autoimmune disorder.   On 23rd July 2019, the patient received the 2nd dose of Shingrix. In July 2019, less than a week after receiving Shingrix, the patient experienced general body pain, muscle pain, joint pain, headache, tiredness, fever, feeling hot, sweating and clamminess. On an unknown date, the outcome of the general body pain, muscle pain, joint pain, headache, tiredness, fever, feeling hot, sweating and clamminess were not recovered/not resolved.   It was unknown if the reporter considered the general body pain, muscle pain, joint pain, headache, tiredness, fever, feeling hot, sweating and clamminess to be related to Shingrix.  Additional information received were as follows: This case was reported by the patient's husband. The patient received 2nd dose of Shingrix on left arm. The patient experienced adverse events like body ache, muscle ache, joint pain, headache, tiredness, fever with hot and sweaty and feeling clammy. This case has been linked with US2019134786, reported by the same reporter.
patient was pregnant while taking BNT162B2; patient was pregnant while taking BNT162B2; Miscarriage 11 days post vaccine; This is a spontaneous report from a contactable Nurse. A 39-year-old female nurse reported that she received first dose of  BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EL0142), into the left arm on 28Dec2020 at 07:30 AM at single dose for COVID-19 immunization. Medical history included asthma and eosinophilic esophagitis and allergies to Keflex ASA. Concomitant drugs were none. At the time of vaccination the patient was pregnant, her last menstrual date was on 20Nov2020, gestational period 6. The patient reported that on 08Jan2021 at 12:00 PM she had miscarriage 11 days post vaccine. The patient was seen at Doctor or other healthcare professional office/clinic visit. At the time of reporting the patient was recovering.; Sender's Comments: Based on temporal association, a possible contributory role of BNT162B2 cannot be completely excluded for reported miscarriage.  However, information is limited, and miscarriage is multifactorial event.  In the general population, the estimated background risk of miscarriage in clinically recognized pregnancies is 15% to 20%. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.