chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Within 5 minutes I Became extremely hot.  It started from feet up to face, heart palpitations.  I could feel my heart beating in my chest.  Uneasy feeling, something was wrong.  Dizzy,  remained with ice pack and wet towel for 20 minutes.  After I left I felt off and dizzy.  I had a difficult time driving .     That evening I had soreness at injection site for 3 days.  Headache and dizziness for 3 days.  Chills for 1 day.  Back pain  and hip pain still to this day.
Hives on both wrists and left butt cheek, bumps on wrists and butt cheeks, rapid breathing
Diffuse Joint stiffness and pain, limiting ambulation, Arthritis spine, spinal stenosis
Headache, Myalgia, Fever, NauseaVomiting, fatigue, injection site pain
Lack of effect; He tested positive for COVID; Flehm; General/muscle fatigue; 36 hours sleeping (for two days was bent out); Headache; Headache after second dose/massive headache; Fatigue after second dose/general fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCTIVE COUGH (Flehm), MUSCLE FATIGUE (General/muscle fatigue), SOMNOLENCE (36 hours sleeping (for two days was bent out)), DRUG INEFFECTIVE (Lack of effect) and COVID-19 (He tested positive for COVID) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040B21A and 038A23A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced HEADACHE (Headache after second dose/massive headache) and FATIGUE (Fatigue after second dose/general fatigue). On 14-Nov-2021, the patient experienced DRUG INEFFECTIVE (Lack of effect) and COVID-19 (He tested positive for COVID). In November 2021, the patient experienced PRODUCTIVE COUGH (Flehm), MUSCLE FATIGUE (General/muscle fatigue), SOMNOLENCE (36 hours sleeping (for two days was bent out)) and HEADACHE (Headache). At the time of the report, PRODUCTIVE COUGH (Flehm), MUSCLE FATIGUE (General/muscle fatigue), SOMNOLENCE (36 hours sleeping (for two days was bent out)), DRUG INEFFECTIVE (Lack of effect), COVID-19 (He tested positive for COVID), HEADACHE (Headache after second dose/massive headache), FATIGUE (Fatigue after second dose/general fatigue) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Nov-2021, SARS-CoV-2 test: positive (Positive) Positive.         No Concomitant medication were reported. No Treatment medication were reported.  Company comment: This is a spontaneous case concerning a 50-year-old male patient, with no reported medical history, who experienced the non-serious  unexpected event of special interest COVID-19. The event occurred more than 6 months after the second  dose of mRNA-1273.  Patient reports productive cough, headache, muscle fatigue and somnolence and tested positive for COVID-19. Lack of effect was also captured a an event. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2021-386972 (Patient Link).; Sender's Comments: This is a spontaneous case concerning a 50-year-old male patient, with no reported medical history, who experienced the non-serious  unexpected event of special interest COVID-19. The event occurred more than 6 months after the second  dose of mRNA-1273.  Patient reports productive cough, headache, muscle fatigue and somnolence and tested positive for COVID-19. Lack of effect was also captured a an event. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Information has been received from a Licensed Practical Nurse referring to a patient of unknown age and gender. Medical history and concurrent condition of the patient was not reported. The patient was vaccinated with two doses of GARDASIL (lot # J009788, expiration date 17-MAR-2016, dose was unknown, intramuscular) which underwent an unsupported temperature excursion on 08-AUG-2014 and 09-SEP-2014 respectively. This is one of several reports received from same reporter. Additional information has been requested.
After the second dose my heart rate has gone up and I feel not good. I have been miserable. I do not know if it is related or not. I went to the cardiologist and all he did was give me more heart rate medicine. He just did an EKG and they were fine and it was ok to take the medicine. I have been on numerous antibiotics since then. I have been to the emergency room multiple times for the heart rate and they really did not do anything. They just put me back on steroids and antibiotics. I have been hospitalized about 6 times for 10 days for the same thing.
Hyperbillirubinemia: nausea, vomiting. Started one day after receiving the vaccine
36 hrs after vaccine, local reaction of redness 4 inch oval, warmth, tenderness, resolved after 36 hrs to just small pink papule at vaccine site. use Motrin, ice prn
Felt like I was getting a cold 2 months after vaccine. Took a home COVID-19 test and was positive. Called my doctor and was prescribed PAXLOVID; Then the next day started feeling like I couldn't breathe and went to an ER; was given an EKG and chest X-ray and a blood test, results were negative. Was given a shot of pain medication while there. Wasn't hospitalized; took another home COVID-19 test 10 days later and it was negative. Followed up with doctor regarding blood testing results, found that I had elevated white blood cell count.
Patient had no adverse reaction after 15 minute waiting period in the pharmacy. Pharmacy staff will follow up with patients parents in future.
Had the Flu and pneumonia shots - the next day had a rash on (R) leg that covered the lower part of his leg - He went to the doctor and he said that it was due to the flu shot. He has had scarring and permanent disfigurement of the skin on the leg - He has been on BENADRYL and top cortisone cream.
"Covid arm" not seen in previous 2 shots but with 3rd, booster shot. Redness, swelling, itching, rash on arm, occurring within 24 hrs after receiving vaccine, not right away. Other symptoms included fever, chills, headache, nausea, aches, fatigue within 12 hours of shot. These symptoms same as when I got second shot. Only new symptom with 3rd shot was "covid arm." Still have rash/swelling 3 days later.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 29Oct2021 as dose 3 (booster), single (Lot number: 301308A), in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: Oxygen saturation: low o2 (94), notes: low o2 (94); SARS-CoV-2 test: Unknown results, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19. Anti-viral details: Brand=Paxlovid, started on 21May2022 and stopped on 25May2022. On 02Jun2022 10:00 PM, the patient had Coughing fits, short of breath, chest tightness, low o2 (94), not treatment received for this and not recovered from this event.
This spontaneous report was received from a medical assistant refers to patient of unknown age and gender. On 23-JUN-2014, the patient were vaccinated with GARDASIL (0.5 ml, lot#J011272, expiration date: 21-APR-2016) intramuscularly which underwent a temperature excursion. No adverse events were reported. At the time of the report action taken with GARDASIL was unknown. This is one of several reports from the same source. Additional information has been requested.
Subsequent to the vaccine, patient developed palpitations and intermittent angina. Bedside monitor documented at least one 13-beat run of slow ventricular tachycardia in February, 2022. Symptoms lasted approximately 4 months. Symptoms resolved since approximately April 2022.
On Day 3 after the shot, experienced acute pain and stiffness in all joints and lower back--level 6 pain in both knees, both hips, and all thigh muscles--as if injury sustained.  Impaired my ability to walk.  Treated with Ibuprofen.  Days 4, 5, 6 improved slightly, but left knee and hip remained unchanged--stiff and very painful.  Attempted 20 mins. of cycling to loosen joints, without success. Day 7 relapsed; left knee and hip worsened.  Stayed home from work; lay down; continued Ibuprofen; could not find comfortable position.  Day 8 resumed work, still limping.  Three weeks later (6/23)--though still somewhat stiff and sore, attempted to mount and ride a horse.  Crippled me.  Went to PCP and received two months of physical therapy, and continue to experience residual (albeit relatively minor) effects today.
PATIENT RECEIVED JANSSEN COVID IMZ, RELOCATED TO CHAIR TO WAIT  HIS 15 MINS POST VACCINATION.  ABOUT 5 MINUTES AFTER RECEIVING SHOT, PATIENT GO LIGHT HEADED AND TRIED TO CALL FOR HELP BUT FELL FORWARD OUT OF CHAIR BEFORE ABLE TO DO SO.  HE HIT HIS FOREHEAD ON THE FLOOR AND CAME TO IMMEDIATELY.   OFFERED FOR PATIENT TO LAY DOWN, BUT REFUSED.   HE SAT ON THE FLOOR AND SAID HE FELT BETTER.   TECH REMAINED WITH HIM UNTIL HE WAS READY TO LEAVE.  HE FELT FINE BEFORE LEAVING WITHOUT ANY COMPLAINTS AND DIDN'T WANT TO FILL OUT ANY PAPERWORK TO REPORT THE INCIDENT.
Day 1, Paresthesias in  my feet, weakness in legs.  Day 4, nasal congestion, feverish, malaise, anorexia, intermittent paresthesias, SOB, Chest Discomfort for 14 days straight, slightly better today.
This spontaneous report as received from a pharmacist refers to a patient of unknown age. On an unknown date, the patient was vaccinated with RECOMBIVAX that went through an unsupported temperature excursion from 29-OCT-2013 to 06-NOV-2013 (dose, route and lot number were not provided). No concomitant medications were reported. No adverse effect reported. This is one of several reports received from the same source (MARRS# 1311USA003162, MARRS# 1311USA004586 and MARRS#1311USA004588). Additional information has been requested.
Diarhhea; injection site swollen; injection site red; injection site itchy; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarhhea), VACCINATION SITE SWELLING (injection site swollen), VACCINATION SITE ERYTHEMA (injection site red) and VACCINATION SITE PRURITUS (injection site itchy) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, the patient experienced VACCINATION SITE SWELLING (injection site swollen), VACCINATION SITE ERYTHEMA (injection site red) and VACCINATION SITE PRURITUS (injection site itchy). On 10-Feb-2021, the patient experienced DIARRHOEA (Diarhhea). On 11-Feb-2021, DIARRHOEA (Diarhhea) had resolved. At the time of the report, VACCINATION SITE SWELLING (injection site swollen), VACCINATION SITE ERYTHEMA (injection site red) and VACCINATION SITE PRURITUS (injection site itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. Treatment details included over the counter anti itch cream, Pepto Bismol.
ABOUT 24 HRS AFTER 2ND DOSE OF PFIZER COVID-19 VACCINE RECEIVED AT DIFFERENT LOCATION, PT DEVELOPED ITCHY SPOTS AND HIVES ON LEFT ARM BELOW VACCINE ADMINISTRATION SITE, ON ABDOMEN, AND RIGHT LOWER LEG. NO REACTIONS REPORTED FROM FIRST DOSE OF PFIZER VACCINE ON 3/27/21. IMPROVING W/BENADRYL.
dermatographism; trouble swallowing; throat closing up; rash all over the body; ear hot and red; Hives; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 26-Feb-2021 and was forwarded to Moderna on 27-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of MECHANICAL URTICARIA (dermatographism), DYSPHAGIA (trouble swallowing), THROAT TIGHTNESS (throat closing up), RASH (rash all over the body) and ERYTHEMA (ear hot and red) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025L20A and 015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MECHANICAL URTICARIA (dermatographism), DYSPHAGIA (trouble swallowing), THROAT TIGHTNESS (throat closing up), RASH (rash all over the body), ERYTHEMA (ear hot and red) and URTICARIA (Hives). At the time of the report, MECHANICAL URTICARIA (dermatographism), DYSPHAGIA (trouble swallowing), THROAT TIGHTNESS (throat closing up), RASH (rash all over the body), ERYTHEMA (ear hot and red) and URTICARIA (Hives) outcome was unknown.            No concomitant medication were reported No treatment medication were reported. The patient received both scheduled doses of mRNA-1273 prior to the event, therefore action taken with the drug in the event is not applicable
Racing Heartbeat/Weakness -- half hour after injection; resolved on it's own Rash on ride side of torso -- rash was not noticed until several hours later (it was warm to the touch, was not raised not raised but more like sunburn and turned white upon pressing) and then resolved; rash reappeared on March 18 and resolved  *photos available upon request
First pregnancy, estimated date of delivery 02/25/2022. PCR tested positive for COVID-19. Treated with Paxlovid.
Site: Swelling at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Medium
8/25/2021 started with tingling in feet then toes were numb. Then left leg started tingling and hurt. Then finger tips were tingling. Then right leg started tingling. 8/26/2021 both leg are tingling like they are going to sleep. Tingling feeling in my neck, back of my head, and up my back. My chest feels like my heart is beating fast.  I feel like there is something crawling under my skin or a sharp zapping pain. I haven't went to the doctor yet. I was trying to wait it out but this is not going away.
Pt received his vaccine and then went to the observation area. While he was there he started feeling lightheaded and unwell. 5 minutes after vaccination, pt was hot, diaphoretic, and went very pale. His eyes started rolling into the back of his head and he was exhibiting shallow breaths. His pupils dilated and he started foaming at the mouth. Pt was lowered to the ground and a full dose of adult epi pen (Lot#0FM406 Exp FEB 2022) was given to the left lateral thigh at 1725. 911 was also called. Pt came to almost immediately. His pupils and breathing returned to baseline. He stayed lying down but was A & O x4. He confirmed that he does not have any allergies, however he has passed out after a vaccine before. Paramedics arrived on scene and took over the encounter. Pt felt much better, however still went with the Paramedics to the ER. Also advised pt to follow up with his PCP in regards to receiving the second vaccine.
No additional AE PQC reported; temperature excursion PROQUAD were administered to 5 patients; This spontaneous report has been received from a physician assistant concerning to a 2-years-old child patient of unknown gender.  The patient's concurrent conditions, medical history and concomitant medications were not provided.  On 11-AUG-2021, the patient was vaccinated with an improperly stored dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (therapy type: recombinant human albumin (rHA) (route of administration, dose number and dose were not provided) (lot#: T028299, expiration date: 16-FEB-2022) (product storage error) as prophylaxis. The total temperature excursion was above -15 degree Celsius (-5 degree Celsius) for a total time frame of 15 minutes. There were no previous temperature excursions. No additional adverse events were reported.  This case is one of six cases received from the same reporter.; Sender's Comments:  US-009507513-2108USA004878: US-009507513-2108USA004894: US-009507513-2108USA004893: US-009507513-2108USA004896: US-009507513-2108USA004892:
Information regarding Flumist (2003-2004 Formula)(influenza virus vaccine, live intranasal nasal solution (frozen)) was received from a physician regarding a 33 year old female pt who experienced a fever of 102 deg. F., muscle aches, and upper respiratory symptoms (cough).  The pt received a dose on 12/15/03.  The pt's concurrent illness includes allergies.  The pt is otherwise healthy.  Indication for Flumist (2003-2004 Formula) was immunization.  Product was administered on 12/15/03. Dose regimen was 0.5mL (IN).  Concomitant therapy included Flonase (fluticasone propionate) and Singulair (montelukast sodium).  On 12/17/03, 2 days post-immunization, the pt developed a fever of 102 deg. F., muscle aches, and upper respiratory symptoms (cough).  No additional information was available at the time of this report.
Onset of chills within 24 hours, post vax. Pt then noticed swelling and redness at site. 9cm X 6cm induration surrounding injection site with patches of erythema distally and tender but no adenopathy. Started on Keflex 500mg, until completed.
On the morning of day 8 (February 5th) I woke up and noticed that my left arm, where injection had been, was firm to the touch. and had a pink area approximately 2" x 3".  It was a little warm to the touch but not hot.  I had no fever.  I had a slight itch on the area.  Today, Sunday, February 7th, it is still firm but pink area seems to be shrinking and the pink color is fading.   I did not feel this warranted a visit or a call to the doctor
5:40pm - vaccine given       5:50pm -  patients arm and legs begin itching, slight tingling of the tongue 6:00pm - Diphenhydramine injection given IM/RA 50mg/mL. BP 135/95, O2 Sat 96-97%. Dr was contacted via telephone (and continued on the phone until patient left the facility.) 6:25pm - Patient states that itching of extremities seems to be getting a little better, but tingling of tongue seems to be getting worse and now throat is tingling, voice sounds "raspy".  Epinephrine 0.3mg was administered via EpiPen to the left thigh, at the direction of Dr.  6:40pm - Patient was transferred via ambulance to ER for observation.
1-2 hrs p/shot devel fever 101 ax mom gave APAP & fever went down; began vomiting in the evening; mom took pt to ER; began vomiting in the evening; dx gastroenteritis; had not eaten;
Fever rising to 104.7 F over course of afternoon/evening. Vomiting x2. Treated at home with acetaminophen and cold bath. Seizure precautions observed. Yes we know what they are: we have an older child with severe epilepsy. On-call physician unavailable for further advice. Child seems to have recovered except is not speaking words he was previously.
I experienced brain fog for the whole day about 24 hours after receiving my vaccine, and the brain fog was gone the next day. I had no brain fog on the day I received the vaccine.
Muscle pain up to shoulder and neck; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Muscle pain up to shoulder and neck) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYALGIA (Muscle pain up to shoulder and neck). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and GABAPENTIN at an unspecified dose and frequency. At the time of the report, MYALGIA (Muscle pain up to shoulder and neck) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Uncontrollable chills/shaking (first 12 hours), high fever (up to 102 (up and down over 72 hour period), headache (4 days), nausea (first 24 hours), diarrhea (on day 2), body aches (day 3), fever blisters (day 3).
Administered Pfizer COVID vaccine #1 to 15 year old patient.  During his 15 minute wait time, patient's eyes began to flutter and he slumped over.  Pharmacist responded and lowered patient to floor and elevated legs.  He regained consciousness and was able to repeat his name and his location.  First BP was 108/68.  Pt was able to sit in chair and drank an orange juice, but began to shake and tremble and stated his extremities were numb. Repeat BP was 80/48 and EMS was called.  Upon EMS arrival, his pulse and BP had returned to normal.  EMS evaluated and advised that he was ok to return home.
tested positive for covid; tested positive for covid; This is a spontaneous report from a contactable Pharmacist.   A patient of unspecified age and gender received the 1st dose of bnt162b2 (BNT162B2, Lot number not reported), via an unspecified route of administration as single dose on 22Feb2021 for COVID-19 immunisation.  The patient medical history and concomitant medication were not reported.   After receiving the first Covid vaccine on 22Feb2021 the patient tested positive for Covid in 2021 and received casirivimab and imdevimab infusion on 10Mar2021. The patient underwent lab tests and procedures which included covid-19: postive in 2021. The outcome of events was unknown. Reporter queried whether the patient should delay the 2nd COVID vaccine. He was due to receive in on 15Mar. 2021.  Information on the lot/batch number has been requested.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product bnt162b2 to the reported tested positive for Covid cannot be ruled out.
Fever; This case was reported by a consumer via interactive digital media and described the occurrence of fever in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced fever. On an unknown date, the outcome of the fever was unknown.   It was unknown if the reporter considered the fever to be related to Shingrix.     Additional Information: GSK Receipt Date: 03-OCT-2022 Reporter's Comment: This case was reported via interactive digital media. The reporter asked how many days after getting Shingrix shot was it normal to get fever.  Additional supportive information: The follow-up would not possible as no contact details were available.