chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Severely bruised arm; Purple and blue size of soft ball have pictures; This is a spontaneous report from contactable consumer, the patient. A 48-years-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown); via unspecified route of administration in left arm on 02Apr2021 at 15:45 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies to medications, food, or other products. The concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient was not diagnosed with COVID-19 prior to the vaccination. Since the vaccination, the patient had not been tested for COVID-19. On 02Apr2021 at 16:00 the patient experienced arm was severely bruised, purple and blue size of soft ball had pictures. No therapeutic measures were taken as a result of reported events. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The clinical outcome of the events severely bruised arm and purple and blue size of soft ball was unknown.  No follow-up attempts are needed. information about lot number cannot be obtained.
BREAKTHROUGH COVID INFECTION. TESTED POSITIVE ON 11/10/2021. PATIENT FULLY VACCINATED ON 05/08/2021.
pt recv vax & devel an inj site rxn characterized by a 2.5 inch area of swelling, induration & erythema;this is 1 of 6 reports from this facility of inj site rxn p/vax;
NAUSEA SEVERE HEADACHE STIFF MUSCLES (ENTIRE BODY) FEVER CHIVERS (ABOUT 2 HOURS)
Adverse side effects - body aches, body chills and fever ranging from 101 - 102F.
Patient seen in office for routine 1 year check up. During immunizations a combination MMR/Varicella vaccine given instead of single MMR. Patient was also given single Varicella in separate extremity. Error identified upon entry into administration record. Provider notified who will reach out to the family to discuss.
Hives evening of 09/30/09 and 10/01/09 took BEANDRYL and only had problems occur in the evening.
Site: Bruising at Injection Site-Mild, Site: Pain at Injection Site-Mild, Additional Details: I was notified of this today 10/3/2022 by store corporate risk management.  I'm not aware if patient notified us of this event prior.  Patient experienced tingling and numbness in arm and palm after vaccination.
muscle and shoulder pain, with warmth and redness, congestion, headache, R leg soreness, with redness and warmth
left arm red, swollen approximately 3-4 inches wide warm to touch and itching noticed after picking up from daycare in afternoon, day after shots given
admitted after cough for 3 weeks, 20lb weightloss also has prostate cancer.
Information has been received from a "wholesaler" concerning a 71 year old male who on Dec 6, 2002 at 13:00 was vaccinated intramuscularly in the right deltoid with a dose of pneumococcal vaccine 23 polyvalent (lot #644106/0819M). On Dec 6, 2002, the patient developed swelling and weakness of the vaccinated arm, nausea, vomiting, dizziness when he turned his head to either side and a rash. It was also reported that the patient was "very concerned". Unspecified medical attention was sought. As of Dec 27, 2002, it was reported that the patient was still experiencing weakness in the right arm and was now experiencing dizziness when he turns his head from side to side. Additional information has been requested.
cholesterol is high; acid indigestion; This is a spontaneous report from a contactable consumer or other non hcp (patient).  A 58-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; Lot Number: Unknown) via an unspecified route of administration on 07Apr2021 (age at vaccination 58 years) as DOSE 1, SINGLE for COVID-19 immunization. Patient had no known drug allergies. The patient medical history and concurrent conditions was reported as none. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and no other medications within 2 weeks was reported. Prior vaccination the patient was not diagnosed with COVID-19 and since the vaccination the patient has not been tested for COVID- 19. Relevant past drug history was reported as no. The patient previously received other vaccine via an unspecified route of administration administered in arm right on 07Apr2021 (Lot number: Unknown) (age at vaccination 58 years) as dose 2, single. On 22Apr2021, patient experienced cholesterol is high and acid indigestion. It was reported that he has had acid indigestion since the vaccine and have not before. The patient never had cholesterol high before. The events were reported as non-serious. The patient underwent lab tests and procedures which included cholesterol : high on 22Apr2021 (cholesterol is high). It was unknown whether patient received any treatment for adverse events. The outcome of the events was unknown.   Lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further in-formation is expected.
This spontaneous report was received from a registered nurse and refers to unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not provided. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX lot# M037642, expiration date 01-SEP-2018 and lot# M043305, expiration date 26-OCT-2018 (dose, route and site of administration were not reported). No adverse effects reported. Administered doses of vaccine experienced the temperature excursion between -14 to -10 degrees Celsius for 1 hour and 28 minutes. The vaccine experienced previous temperature excursion between -14 to -10 degrees Celsius for 22 minutes. Data logger was involved. No product quality complaint (PQC) was involved. This is one of several cases received from the same reporter. Additional information is not expected, because there was no consent to contact the reporter.  Sender's Comments:  US-009507513-1706USA007129: US-009507513-1706USA006072:
Presented with 3 days of dizziness and shortness of breath, 3 weeks bilateral leg swelling without pain, redness, or warmth. No headaches, no bloody stool, no change in bruising patterns. Patient afebrile, stable vital signs, CBC remarkable for a platelet count of 2000 with immature platelet fraction of 69.8, hemoglobin 10.9, hematocrit 34.1. Diagnosis ITP.
eyes itching, tightness in chest, cough, swelling around his eyes and a bit of difficulty breathing. It was about 4 hours after the shot.
SUSPECTED COVID-19; This spontaneous report received from a patient concerned a 57 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211a21a, expiry: UNKNOWN) dose was not reported, administered on 22-SEP-2021 for prophylactic vaccination. No concomitant medications were reported.  On 06-MAR-2022, the patient experienced suspected covid-19. On 07-MAR-2022, Laboratory data included: SARS-CoV-2 test (not provided) negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from suspected covid-19. This report was non-serious.; Sender's Comments: Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
VERTIGO;UNABLE TO USE ARMS/LEGS;UNABLE TO SPEAK Narrative:
Within 3 hours of the first shot I started to feel like I was having burning menstrual cramps in my abdomen along with feeling like I might have diarrhea. I haven't had a period or period symptoms in over six years since I am on birth control. Right after those symptoms, almost 4 hours after, I began to feel like I was high  for about 3 to 4 hours that feeling lasted. I was still able to concentrate but felt pretty high.  A small symptom from the 2nd vaccine that didn't last long and happened within about 20 hours was the taste of chalk when I ate food. I couldn't taste my breakfast or coffee it just tasted like chalk. That went away by lunch at around noon.
P.C. from mom - reports was given immunizations yesterday has been running fever ever since. Comes down with TYLENOL or ibuprofen but goes back up.
Fatigue and lymph node pain for several days and s(wollen lymph nodes on left side by chest)  I had an episode of lightheadedness and labored breathing for 2 minutes and was unable to think clearly or speak in a sentence for 45 seconds. I had chills and needed to be covered with blankets to feel comfortable again. 2.5 hrs later was feeling better with a  mild headache.
Chronic arthritis in shoulders, knees, wrists, and ankles (not present before vaccine)
Pfizer BioNTech COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Pfizer Vaccine on 05/06/2021 and 06/03/2021. Patient presents to ER on 8/6/2021 referred directly from outpatient clinic with chief complaint of fever, chills, chest pain and dyspnea times 3 days. He was admitted to medical floor 08/06/2021 for acute hypoxemic respiratory failure secondary to COVID pneumonia requiring 2 L supplemental oxygen via nasal cannula. Patient received remdesivir, ceftriaxone, Bactrim and Baricitinib. On 08/10, oxygen demand increased from 7 L nasal cannula to high-flow nasal cannula 40 L 40% FiO2.  Oxygen demand slowly increased requiring 60 L 100% FiO2. Patient was transferred to ICU for worsening hypoxia. 8/14-8/15 patient remained on HFNC and desaturated in the 50s. 8/15 patient left the hospital against medical advice. Patient expired on 8/26/21.
Feeling horrible; High fever (not confirmed using a thermometer); Shakes; Dizziness; Feeling of vomiting; The worst muscle aches ever had; Increased heart rate of 20 beats higher than normal; This case was reported by a consumer via call center representative and described the occurrence of feels awful in a 61-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included atrial fibrillation and coronary stent placement.   On 26th October 2020, the patient received the 2nd dose of Shingrix (intramuscular). In October 2020, less than a week after receiving Shingrix, the patient experienced feels awful, fever, tremor, dizziness, nausea, muscle pain and heart rate increased. On an unknown date, the outcome of the feels awful, fever, tremor, dizziness, nausea, muscle pain and heart rate increased were not recovered/not resolved.   It was unknown if the reporter considered the feels awful, fever, tremor, dizziness, nausea, muscle pain and heart rate increased to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix on upper left arm and feeling horrible, and experiencing a high fever not confirmed using a thermometer, shakes, dizziness, feeling of vomiting, the worst muscle aches ever had and an increased heart rate of 20 beats higher than normal. The patient stated had A.fib with a heart stent. The reporter did not consent to follow up. Not all information was available and did not want to provide further adverse event details and other information because they were not feeling well.
Shaking; Chills; Headache; Myalgia; Fatigue; A spontaneous report was received from a healthcare professional concerning a male   patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events shaking, chills, headache, myalgia, fatigue.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On unknown date, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the event(s) shaking, chills, headache, myalgia, fatigue.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), shaking, chills, headache, myalgia, fatigue was unknown.
Itching in sensitive areas around the body; Eyes started itching; Itching in lips; Eyes started watering; Itching in nose; This spontaneous case was reported by a pharmacist and describes the occurrence of PRURITUS (Itching in sensitive areas around the body), EYE PRURITUS (Eyes started itching), LIP PRURITUS (Itching in lips), LACRIMATION INCREASED (Eyes started watering) and NASAL PRURITUS (Itching in nose) in a 47-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 (No medical reported history).    On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Dec-2020, the patient experienced PRURITUS (Itching in sensitive areas around the body), EYE PRURITUS (Eyes started itching), LIP PRURITUS (Itching in lips), LACRIMATION INCREASED (Eyes started watering) and NASAL PRURITUS (Itching in nose). At the time of the report, PRURITUS (Itching in sensitive areas around the body), EYE PRURITUS (Eyes started itching), LIP PRURITUS (Itching in lips), LACRIMATION INCREASED (Eyes started watering) and NASAL PRURITUS (Itching in nose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   This case concerns a 47-year-old female who experienced NS events of unexpected pruritus, nasal pruritus, lip pruritus, eye pruritus, and lacrimation increased.  Event onset occurred the same day as the first dose of mRNA-1273. Treatment with Zyrtec and Pepcid. Events resolved. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Reporter's Comments: This case concerns a 47-year-old female who experienced NS events of unexpected pruritus, nasal pruritus, lip pruritus, eye pruritus, and lacrimation increased.  Event onset occurred the same day as the first dose of mRNA-1273. Treatment with Zyrtec and Pepcid. Events resolved. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
SX began 05/03/06 pm after injection site a small bump, arm red from shoulder to elbow, warm to touch, not itching. At that point pts wife stated he had Pneumovax 1/05, Pt did not remember.
On 9/1/01, this young girl came in and has a red, itchy rash on her arms and upper thighs. She stated "I think it was from my Hep-B shot". Treatment: given 50mg, IM, of Benadryl.
Patient started to feel nausea, dizziness, perspiration,  and chest pain. with in 30 mins of taking the vaccine.  Patient repeated saying she has chest pain and wanting to lay down and having continuously feeling dizzy.   Patient had palpitation and BP was un reported
Patient experienced swelling of the right deltoid muscle. Patient noticed swelling in the evening after receiving vaccine in the morning. Patient self treated with warm compresses. Stated the swelling had gone down by the time he came into the pharmacy the next morning to report. Instructed patient to continue to use warm compress and to alternate with cold compress. Also instructed patient to lie down and keep arm above heart to promote swelling to decrease.
This is a spontaneous report from a contactable physician. This report was received via a Pfizer sales representative. A female patient of unspecified age (reported as over age 65) received PREVNAR 13, via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced shoulder and arm swelling, redness, pain after use of product on an unspecified date. The outcome of the events was unknown. No follow-up attempts are possible; information about batch number cannot be obtained.
positive test confirmed by PCR; positive test confirmed by PCR/a fever for about 3 days, severe headache, ear pain and lethargy; This is a spontaneous report from a contactable consumer (wife of patient). This consumer reported for 47-year-old male patient (husband). A 47-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot number: UNKNOWN), via an unspecified route of administration as dose 2, single on 13Apr2021 and dose 1 via an unspecified route of administration as dose 1, single on 23Mar2021 both for covid-19 immunisation. The patient medical history included prior pulmonary embolism (PE) due to a surgery in 2019. The patient's concomitant medications were not reported. As per reporter, patient received his first vaccine dose on 23Mar2021 and his second on 13Apr2021. Patient had a positive test confirmed by PCR (medically significant) on 26Aug2021. Patient had a telemed appointment with his doctor today and patient's partner was surprised by his symptoms despite being fully vaccinated.The patient had a fever for about 3 days, severe headache, ear pain and lethargy. Reporter thought he might have the delta variant and she was wondering if he would be able to get tested to see if has it. Lab tests and procedures which included SARS-COV-2 test: positive on 26Aug2021 positive test confirmed by PCR. At the time of this report, outcome of event was unknown.  The lot number for the vaccine [BNT162B2], was not provided and will be requested during follow-up.
horrible pain in the arm where got vaccine since they gave me vaccine, been taking pain meds but isn't helping, feeling shortness of breath and fatigue and headaches since receiving vaccine.
newly FDA (Food and Drug Administration) authorized Moderna bivalent formulation has a slightly higher dosage than what their child recently received. According to the guidelines from the CDC (Centers for Disease Control and Prevention), it is recommended that we repeat their child?s most recent dose of COVID-19 vaccine to ensure proper protection.  No adverse effects noted.
This spontaneous report as received from a physician refers to a female patient of currently 62 years old. The patient has may medical issues. On 15-NOV-2012, the patient was vaccinated with a single 0.5 cc dose of intramuscular PNEUMOVAX 23 (lot#H013399; exp date: 07-MAR-2014). Concomitant therapy includes ABILIFY, AMITIZA, atorvastatin, lorazepam, levothyroxine, mirtazapine, omeprazole, Pinaverium Bromide, SENOKOT and zolpidem tartrate. On November 2012, the patient experienced swelling, tenderness and paim at injection site and seek medical attention. The patient Doctor stated that she had a rather severe local reaction above and a bruised area. The patient was treated with glucocorticoid, antibiotic. It was reported that the patient was all better in November 2012. The relatedness of the event with PNEUMOVAX 23 was unknown. No further information provided. Additional information has been requested.
Patient contracted COVID despite Moderna vaccination on 1-29-2021 and 2-27-2021.  She developed symptoms on 7-30-21 after contact with COVID positive resident at her living facility.  Tested positive for COVID-19 with rapid antigen test on 8-2-2021.  Mild upper respiratory symptoms.
pt recvd vax 27AUG92 & 31AUG92 Pm pt felt bad; 1SEP92 exp sneezing & felt achy in head; events persist;
I noticed a tingling sensation on my in my left arm that goes goes about mid way from my bicep to my hand.  It is best described as when your hand falls asleep and your getting sensation back, that pins and needle feeling.  When condition first occurred I figured it may have been dry skin as I just got done on 5/23/2021 working heavily in the sun and had a mild sunburn.  I did not even apply skin lotion at this time.  I did not notice anything unusual on 5/24/2021 as I worked hard the day before and my arms were tired.  On 5/25/2021 I noticed it and it still felt like a tired arm but the tingling never left.  While it is not painful or debilitating it's presence is known and is uncomfortable.    I have held my arm up and performed other tests to rule out stroke.  AT this time I am reporting it and will continue to monitor the situation and alert you if it gets worse or gets better.
10/6/2023 (24 hrs post):  Mild headache, sore throat, tiredness; headache and sore throat resolved with acetaminophen.  10/7/2023 (33 hrs post): ~2 hrs after retiring, awoke abruptly with acute depression: overwhelming invasive thoughts of lack of self-worth, dread and anxiety. Took 1 hr to return to a troubled sleep.  10/7/2023 (41 hrs post): Awoke listless with pervasive invasive feeling of worthlessness,  depression, uncontrollable sobbing. No suicidal thoughts, but a desire to sleep forever or just disappear.  10/7/2023 (45 hrs post): Overwhelming fatigue, slept ~3 hours. Afterwards, was tired but  depression/invasive thoughts were absent. 10/8/2023: Woke with normal stamina and demeanor I am a 66 year-old retired physician, active with no chronic medical conditions and no history of mental illness/severe depression. The depressive episode was acute in both onset and resolution. Curiously, although the feelings seemed true and certainly frightened my spouse, my underlying rational thought processes, such as the ability to search for the reported rare side effects of the vaccines, remained unchanged throughout the episode.
Patient had headache, body aches, fever, starting about 8-10 hours after injection.  Effects are subsiding at this time, 11 AM, 9/3/20 (21 hours after injection)
Shortness of breath and panic - feeling of loss of control; worry and anxiety. The severe symptoms lasted about five hours. And then management symptoms I am still experiencing. I saw my social worker/licensed. She recommended that I recommend to go to a Psychiatrist to talk about medication for the symptoms. The only thing I'm using for treatment is yoga, deep breathing and meditation and that seems to help.  Pregnancy history -2nd pregnancy - 1st pregnancy - successful live birth;  estimated date of delivery for this 10/10/2021.
I received the shot at 2:30 pm while at work about 5 minutes later I became nauseated, felt a warm sensation down the center of my chest, then difficulty breathing, by 2:45 pm I was placed on a gurney at which time I started having facial twitching on the left and right side of my face, then I was unable to speak. At 3:00 pm I was given an IV injection of ATIVAN 0.5mg and I was also given an IM injection of BENADRYL 50mg, they did a EKG and CT to rule out stroke both were negative, my blood pressure was elevated 161/93 respirations 25 and temperature 99.1. When I was able to speak again I was stuttering and facial twitching continued, I had uncontrollable jerky movement of my left arm, in which the intradermal shot was administered (paresthesia) I was treated in the ER Dept were I worked as an Admission Nurse from approximately 2:45 pm to 6:15 pm when I was discharged home and told to follow up with my PCP the next day. In the days and weeks following the flu shot my symptoms have increased headaches, muscle and joint pain, swelling in my fingers, numbness and tingling in my feet and calves, difficulty with memory, unable to do much without becoming very tired, ringing in my ears that makes me have the feeling of electrical jolts from my head to my feet, and I continue to stutter. I saw a neurologist on December 10, 2013 and he diagnosed me with dysarthria and hemifacial spasms and in his notes observed me having dysnomia.