chrisvoncsefalvay/vaers-outcomes huggingface dataset:
violently shaking; fever 100.4; arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (violently shaking), PYREXIA (fever 100.4) and PAIN IN EXTREMITY (arm was sore) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027A21A and 021B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), RIVAROXABAN (XARELTO), LABETALOL, ALPRAZOLAM and ZOLPIDEM TARTRATE (AMBIEN) for an unknown indication.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 11-Mar-2021, the patient experienced PAIN IN EXTREMITY (arm was sore). On 09-Apr-2021, the patient experienced TREMOR (violently shaking) and PYREXIA (fever 100.4). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency. At the time of the report, TREMOR (violently shaking), PYREXIA (fever 100.4) and PAIN IN EXTREMITY (arm was sore) outcome was unknown.            Current condition includes Carotid heart disease.
Around five hours after shot I felt what I would describe as brain fog and light headache, by the evening I was aching, chilling and had 101 fever. Aches in my muscles and joints as if I had Rocky mountain spotted fever again. That is what the side effects reminded me of. This went on for over 48 hours. I have never been so sick. Very nauseous by next day. Also fell to the floor from nearly passing out the following morning. Took a minute for the light headed To pass. Arm pain still today. It was very scary and seemed to be a very serious reaction. Friday after noon finally started feeling better. The other strange part of this is that my daughter and best friend and I received the shot together in the same lot number and every one of us was deathly ill with the same symptoms. I am the only one with the fainting spells. Still feel fatigued today. And shoulders and left arm injection site still sore and achy.
Swollen armpit gland in injection arm, appearing approximately 36 hours after injection.  Swollen and painful.
Patient did not got the second dose; felt hot and cold; Felt like she had a fever; Feeling like she needed to vomit but did not; Blood pressure dropped; Experienced dizziness; Weakness; Uncontrollable shakes; Clamminess; Was hot and cold; Felt like she could not move her arms for 3 straight days because it was so painful; Fast heartbeat; This spontaneous case was reported by a consumer and describes the occurrence of HYPOTENSION (Blood pressure dropped), DIZZINESS (Experienced dizziness), ASTHENIA (Weakness), TREMOR (Uncontrollable shakes) and COLD SWEAT (Clamminess) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced HYPOTENSION (Blood pressure dropped), DIZZINESS (Experienced dizziness), ASTHENIA (Weakness), TREMOR (Uncontrollable shakes), COLD SWEAT (Clamminess), FEELING HOT (Was hot and cold), PAIN IN EXTREMITY (Felt like she could not move her arms for 3 straight days because it was so painful), TACHYCARDIA (Fast heartbeat), FEELING COLD (felt hot and cold), PYREXIA (Felt like she had a fever) and NAUSEA (Feeling like she needed to vomit but did not). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Patient did not got the second dose). On 28-Jan-2021, HYPOTENSION (Blood pressure dropped), DIZZINESS (Experienced dizziness), ASTHENIA (Weakness), TREMOR (Uncontrollable shakes), COLD SWEAT (Clamminess), FEELING HOT (Was hot and cold), TACHYCARDIA (Fast heartbeat), PYREXIA (Felt like she had a fever) and NAUSEA (Feeling like she needed to vomit but did not) had resolved, FEELING COLD (felt hot and cold) outcome was unknown. On 31-Jan-2021, PAIN IN EXTREMITY (Felt like she could not move her arms for 3 straight days because it was so painful) had resolved. At the time of the report, PRODUCT DOSE OMISSION ISSUE (Patient did not got the second dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication details not reported by the reporter.    Most recent FOLLOW-UP information incorporated above includes: On 02-May-2021: Follow up received on- 02-MAY-2021, New event updated.
38 year old White male with limited past medical history who was in his usual state of health until approximately Thursday evening.  Patient had received the Covid vaccine, second dose on Thursday evening and on Friday had started to experience centralized pressure in his upper chest that radiated to his throat.  Patient rates the intensity at approximately a 5 out of 10.
The Moderna COVID-19 shot was given to a 16 year old. This is an adverse event because it is only approved for those 18 years and older right now.
p/vax pt devel more than 50 chickenpox lesions all over body w/pruritus;pt sought unspecified medical attention & was treated w/acyclovir;no fever was reported;
Site: Pain at Injection Site-Mild, Systemic: Body Aches Generalized-Mild, Systemic: Joint Pain-Mild, Additional Details: Pt claimed that after 6 days after vaccination, his left arm is still sore when moved.  He also claimed that he is limited mobility of his left arm due to the vaccine with out feeling some level of pain.
Really swollen lymph node in her axillary; Soreness in arm; A spontaneous report was received from a 42-year-old female consumer, who received Moderna's COVID-19 vaccine and experienced soreness in her arm and really swollen lymph node in her axillary.  There were no medical history and concomitant medications reported.  On 23 DEC 2020 the patient received the first of the two planned doses of mRNA-1273 vaccine intramuscularly in her left arm for the prophylaxis of COVID-19 infection.  The patient experienced soreness in her arm on 24 DEC 2020 and really swollen lymph node in her axillary on 28 DEC 2020 and got more painful over the course of the day on 28 DEC 2020. As of 29 DEC 2020, it was not that swollen unless she touched it.   Treatment received for soreness in arm, really swollen lymph nodes was not provided.   Action taken with the second dose of mRNA-1273 vaccine in relation to reported events was not provided.  Outcome of the events, soreness in arm and really swollen lymph nodes was not provided.; Reporter's Comments: This case concerns a 42-year-old female patient, who experienced expected non-serious events of Injection site pain and Injection site lymphadenopathy. The event of Injection site pain occurred approximately one day after first dose of mRNA-1273, lot # unknown. The event of Injection site lymphadenopathy occurred approximately five days after first dose of mRNA-1273, lot # unknown. Treatment information was not provided. Based on the current available information and temporal association between the use of the product and onset of the events a causal relationship cannot be excluded and the events are considered possibly related to the vaccine.
Havrix that had expired on January 30th 2023; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 47-year-old female patient who received HAV (Havrix) (batch number H4H53, expiry date 30-JAN-2023) for prophylaxis.   On 01-FEB-2023, the patient received Havrix. On 30-JAN-2023, an unknown time after receiving Havrix, the patient experienced expired vaccine used (Verbatim: Havrix that had expired on January 30th 2023). The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 20-MAR-2023 The patient received  a dose of Havrix on 1st February 2023 that had expired on January 30th 2023, which led to expired vaccine administered. The nurse asks if the dose is valid. The vaccine administration facility is the same as primary reporter. The reporter did not consent to follow-up.
Had itchy rash that appeared on her arm of the injection site, which proceeded to spread to both arms and back. Nurse Supervisor gave Benadryl and that stop the symptoms. No other complications
Woke up from sleep to go the bathroom.  Felt weak when walking, once in the bathroom my vision went dark not able to see out of the sides of my eye it kind of went dark.  My ears started ringing loudly and i felt a bit off balance.  The vision came back after ~20 minutes and the ringing took ~2 hours to fully go away.
Urticaria at injection site noted after administration of vaccine. 1 tsp BENADRYL given start: 2 doses of steroid for HS and next day AM.
Shortness of breath weakness- within 2 weeks of 2nd dose of the vaccine New onset multifocal ventricular arrhythmia- Note 3 weeks after the vaccine seen on Holter  Monitor 5/20/21,  Trans thoracic Echo 5/20/21 LV low end of normal then Nuclear stress treadmill 5/20/21 VEF 33% with low probability of coronary stenosis or ischemia New onset atrial dilation- Noted on cardiac tests CT CCTA w Contrast showed  LV ejection fraction 26% Cardiac MRI -9/28/21 dilated cardiomyopathy with basal septal and inferior scarring of mid to lower myocardium due to myocarditis. Heart Failure Myocarditis  Heart Failure New Onset Atrial Fibrillation
Nasal and chest congestion set in about 2 weeks after the injection and has lasted 6 weeks (not sure if this is connected to the Zoster). Iritis in the right eye set in on March 11, 2019 with redness, pain and light sensitivity. The redness came on in the morning, the pain hit suddenly at 5:00 PM.
Became short of breath  and he had an enlarged heart and myocarditis low heart  function. It was a surprise to cardiologist as he was just cleared for surgery. They told me he may have gotten a silent virus. . It was 1 month since 2nd Pfizer vaccination. Died within 7 days of symptoms. Doctors were very surprised.
seizures; This is a spontaneous report from a contactable consumer (patient). A 22-year-old female patient received the first dose of BNT162B2 (BNT162B2) via an unspecified route on left arm 1st dose, single for COVID-19 immunization on 28Apr2021 01:00 at 22-year-old. Medical history included cerebral palsy. There were no concomitant medications. The patient experienced multiple side effects throughout the day followed by seizures on 28Apr2021 17:00, reported as serious due to disability with outcome of recovering. Doctor or other healthcare professional office/clinic visited, emergency room/department or urgent care visited, reported as disability or permanent damage. The patient was treated by diphenhydramine hydrochloride (BENADRYL).  Information on Lot/Batch number has been requested.
Early and shortened menstrual cycles. First cycle post vaccine was 25 days and second cycle was at 24 days, both being very short at only 1.5 days. As someone who has been trying to conceive for the past 2 years, my menstrual cycle is being tracked carefully and regularly with a cycle length consistently averaging 28 days and menstrual length of 3-4 days. It's unknown yet if there will be additional shortened cycles or any additional changes as I have only had two cycles since receiving the second vaccine.
2 days after the vaccine pt developed a stomach ache radiating to the back ,after several tests and seven weeks later pt. was diagnosis   with multiple myeloma went blind and passed away,
Vomiting, Fatigue, Fever, Chills, Muscle soreness  Treated with OTC pain relievers and sleep.
about 5 minutes after administration pt fainted. pt was in the company of his mother who stated pt quickly regained consciousness.  we offered to call the paramedics pt's mother refused reassuring us her son was fine. several hours later we tried contacting pt at the phone number listed on their file but could not reach the pt and could not leave a message
Prolonged and heavier menstrual cycle after first dose.; This is a spontaneous report from a non-contactable other health care professional. A 25-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number andExpiration Date: not reported), intramuscularly administered in left arm on 20Jan2021 at  09:15 (reported as 09:15 AM) (at the age of 25 years old) as first dose, single for COVID-19 immunisation in a Nursing Home/Senior Living Facility. Patient was not pregnant and has no known allergies. Prior to vaccine the patient was not diagnosed with COVID-19 and no other medical history was reported. Patient's concomitant medications were not reported. The patient did not receive any other vaccines in 4 weeks and no other medications in 2 weeks. On 21Jan2021, the patient experienced prolonged and heavier menstrual cycle after first dose . No treatment was given as response to the adverse event. After vaccination, the patient has not been tested for COVID-19. Outcome of the event was recovered.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Accidentally administered to wrong pt. MA went into the pt's room and asked whether their name was (correct patient's name). Pt confirmed, so injection was administered. Discovered upon leaving the room that it was administered to wrong pt. Pt notified/effects discussed between pt and NP. MD and office manager notified. Process change in place to prevent from happening again. Need to verify pt TELLS US their name/DOB prior to administration.
Sometime after the first dose of the vaccine I was only sleeping 4-5 hours per night, and I was waking up very early. This was not normal for me. I was waking up with a strange feeling like my skin was vibrating and I have a feeling in the pit of my stomach. I also have disjointed thoughts and an inability to picture things. My doctors had differing opinions ranging from mania to depression. I had been suffering from depression early in the spring, but this was totally different. I was prescribed with a mood stabilizer. I still have the warm feeling and vibration in my skin when I get up or I am sitting still. It feels like my skin is warm all over my body but mostly in my arms and hands. After the second vaccine I also have had some hair loss and breakage. It has been three months and it does not seem to be happening any less often or come in shorter bouts. I still have trouble with my thought processes and verbalization. I have conceived since that time, and I am currently six weeks pregnant.
Moderna COVID?19 Vaccine EUA 6 days after injection I had increased itching in the evening. Day 7 after first injection around 9 am, Ihad increased itching and observed redness around the lateral deltoid on the L side with increased swelling. I have no pain or tenderness.
SYRINGES  LOOKED LIKE THEY ALREADY HAD SOMETHING IN THERE, AS IF THE PLUNGERS WERE DRAWN UP; PHYSICIAN BELIEVES 7 PEOPLE DID  NOT GET THE VACCINE (GOT EMPTY VACCINES); This spontaneous report received from a physician concerned multiple patients. 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) dose was not reported, administered on 26-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 26-MAR-2021, the subject experienced syringes looked like they already had something in there, as if the plungers were drawn up. On 26-MAR-2021, the subject experienced physician believes 7 people did not get the vaccine (got empty vaccines). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the syringes looked like they already had something in there, as if the plungers were drawn up and physician believes 7 people did not get the vaccine (got empty vaccines) was not reported. This report was non-serious. This case is associated with product quality complaint, Product Quality number: 90000174637.
I felt worse than the worst case of flu I?ve ever had.  Sinus congestion, head ache, body aches ( upper back & shoulders).  And WEAK!  The congestion and body aches went away in 72 hours.  The weakness improved very gradually over the next week.
Initial unsolicited report received from a healthcare professional via other company (Pfizer) on 02 February 2016. Manufacturer Report Number: 201604309. This case involves 53-year-old female patient who was vaccinated with a dose of Tetanus toxoid (batch number, expiry date, dose, dose in series, route and site of administration were not reported) on an unknown date. The patient's medical history and concomitant medications were not reported. On an unknown date, following the vaccination, the patient had developed allergy to vaccine. The patient's laboratory data and corrective treatment were not reported. The outcome of event was not reported. List of documents held by sender: none.
Fever the following day, nausea, vomiting, body aches. Migraine that would not break. 6 days later I had one of the most intense migraines I?ve ever had, which included severe vomiting.  I also experienced a tingling sensation on my left side - specifically on my left cheek and hand. I also had neck pain.
Swollen & painful Glands, Flushing, Profuse Sweating, Eyes Swolen Shut, Difficulty breathing, blurred vision, feverish. This all started at about 5:30 PM and progressively got worse until a benadryl and advil were taken and I went to bed and and went to sleep. I woke up several hours later feeling much better. All I have this morning is puffy eyes.
pain/soreness at the injection site, swelling, chills, muscle and body aches, headachy a little bit that goes up and down; pain/soreness at the injection site, swelling, chills, muscle and body aches, headachy a little bit that goes up and down; pain/soreness at the injection site, swelling, chills, muscle and body aches, headachy a little bit that goes up and down; pain/soreness at the injection site, swelling, chills, muscle and body aches, headachy a little bit that goes up and down; pain/soreness at the injection site, swelling, chills, muscle and body aches, headachy a little bit that goes up and down; pain/soreness at the injection site, swelling, chills, muscle and body aches, headachy a little bit that goes up and down; It goes up and down, feels sort of like catching the flu; This is a spontaneous report from a contactable Pharmacist reporting for herself.     A 59-years-old female patient received bnt162b2 (BNT162B2) vaccine , intramuscular in the left upper arm on  23Dec2020 10:30 at single dose for Covid-19 immunisation .  Medical history included ongoing hypertension , Covid-19 from 25Mar2020 to an unknown date treated with azithromycin. In Jun2020 she had antibodies against COVID-19. Concomitant medication included hydrochlorothiazide (HYDROCHLOROTHIAZIDE).  The patient experienced pain/soreness at the injection site, swelling, chills, muscle and body aches, headache and feels sort of like catching the flu on 23Dec2020 with outcome of not recovered. The soreness started about 4 hours after the injection and during that night it progressed with the chills and body/muscle aches. Did take Tylenol to help and took it throughout the night and the day after and drinking fluids.  Stated if condition goes on much longer or worse  then she will have to go to the hospital.  Lot/Batch and Expiration date has been requested.
RED SKIN AREA IN THE SHOT; This spontaneous report received from a patient 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) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 13-MAR-2021, the subject experienced red skin area in the shot. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of red skin area in the shot was not reported. This report was non-serious.
Hep A #2 given too soon. Needs to be 6 months between first and second dose in series.
Moderna COVID- 19 Vaccine. Vaccine recipient reported on 1/19/2021 that they received the Moderna Vaccine on 1/8/2021. The following week on 1/15/2021, they reported while driving, their area around their right eye became numb and they began to have blurry vision. The numbness spread to around their face/mouth. They pulled over and their spouse drove him to the hospital. Roughly 20 minutes after the initial symptoms, they developed chest pain and patient reported that the ED noted an abnormality on their EKG. The patient had to be admitted overnight for observation. The patient reported that on 1/18/2021, they still had mild chest pain and facial numbness remains around the right eye, left mouth/cheek area, and tongue. They did develop fever and a headache. The patient reported that on 1/19/2021, they are waiting on results, additional testing, and further follow-up appointment with their provider.
Two weeks after her injection, patient reported noticing after her morning shower a 2" slight redness at site of Moderna injection and "tender." Her temp has been "98.6 or 99.2." No itching or firmness, oozing or lines at the site. Not hot to the touch. No signs of illness. She stated that this reaction was not there before that day on 2/24/21. The first Moderna injection was on 2/9/21.