chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Itchy at injection site; Developed a hard red knot at the injection site; Left arm was really sore at the injection site; Did not have any energy (Felt drained); Developed a hard red knot at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Did not have any energy (Felt drained)), VACCINATION SITE MASS (Developed a hard red knot at the injection site), VACCINATION SITE PRURITUS (Itchy at injection site), VACCINATION SITE ERYTHEMA (Developed a hard red knot at the injection site) and VACCINATION SITE PAIN (Left arm was really sore at the injection site) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040C212A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jul-2021, the patient experienced ASTHENIA (Did not have any energy (Felt drained)), VACCINATION SITE MASS (Developed a hard red knot at the injection site), VACCINATION SITE ERYTHEMA (Developed a hard red knot at the injection site) and VACCINATION SITE PAIN (Left arm was really sore at the injection site). On 02-Aug-2021, the patient experienced VACCINATION SITE PRURITUS (Itchy at injection site). At the time of the report, ASTHENIA (Did not have any energy (Felt drained)), VACCINATION SITE MASS (Developed a hard red knot at the injection site), VACCINATION SITE ERYTHEMA (Developed a hard red knot at the injection site) and VACCINATION SITE PAIN (Left arm was really sore at the injection site) had not resolved and VACCINATION SITE PRURITUS (Itchy at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported  No treatment medications were reported   Most recent FOLLOW-UP information incorporated above includes: On 13-Aug-2021: Non-significant follow-up received.
A 63 year old man received his first OncoTICE instillation on 12MAR2004 at 13:30. At about 17:00 reportedly he presented with dizziness, nausea, facial flushing, blurry vision, headaches and a "taste of medication in his mouth". The symptoms abated after 24 hours. A day or two later he presented with increased urinary frequency and burning during urination. At the time of reporting the burning still lingered.
Have running nose; Weakness; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (Have running nose) and ASTHENIA (Weakness) 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 21-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-May-2021, the patient experienced RHINORRHOEA (Have running nose) and ASTHENIA (Weakness). At the time of the report, RHINORRHOEA (Have running nose) and ASTHENIA (Weakness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication list was not provided. Treatment information was not provided.
No smell; no taste for a bit; This spontaneous case was reported by a consumer and describes the occurrence of ANOSMIA (No smell), AGEUSIA (no taste for a bit) and FEELING ABNORMAL (lousy) in an 81-year-old female patient 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ANOSMIA (No smell), AGEUSIA (no taste for a bit) and FEELING ABNORMAL (lousy). At the time of the report, ANOSMIA (No smell), AGEUSIA (no taste for a bit) and FEELING ABNORMAL (lousy) outcome was unknown.            No Concomitant medication was reported.  No treatment medications were reported.; Sender's Comments: This is a spontaneous case concerning a 81-year-old female patient with no relevant medical history reported, who experienced AESI, non serious, unexpected events of Anosmia and Ageusia. The events occurred unknown days after the second dose of mRNA-1273.    No information about the first dose was disclosed. Rechallenge is not applicable. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Was getting a booster dose of Moderna after receiving first Janssen dose. Pt received 0.5ml in place of the 0.25ml booster dose. As of 12:12pm on 10/27/2021 he reported nothing other than a sore arm.
Vaccines experienced TE and then administered to a patient with no reports of side effects.; Vaccines experienced TE and then administered to a patient with no reports of side effects.; This spontaneous report was received from a medical assistant and refers to a patient of unspecified age and gender.  The patient's concurrent conditions, medical history, previous drug reactions, drug allergies and concomitant therapies were unknown by the reporter.  On 24-JUL-2023, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) recombinant Human albumin (rHa) lot # X007086, expiration date: 04-SEP-2024, administered for prophylaxis (strength, route, and site of administration were not provided). Temperature excursion and time frame were not specified by the reporter, and there was no report of side effects nor product quality complaint was involved.   This is one of two reports from the same reporter.; Sender's Comments:  US-009507513-2307USA011469:
reported receiving 2nd dose on 6/12. TM reported she had some arm soreness at her injection site from first dose on the day she went for her 2nd dose, and felt that nurse put second dose high and close to her shoulder cap in same arm. TM reports she had severe arm pain and couldn't move arm, as of 6/16 it is just tender and pain has improved. advised she can be evaluated and fill out injury report if she'd like. sx following vaccine were headache and nausea onset 6/12, fever of 100.3 onset 6/13 PM, chills and body aches onset 6/14. All sx resolved by 6/15. TM called out 6/14 and 15, waited until fever had been resolved for 24 hours before RTW. TM took zofran for nausea that onset just after receiving vaccine, but headache was severe and taking OTC meds did not help headache.
Tremor in right hand/arm when I left anything. Has continued for past 2 days and is still occurring.
Soreness in the arm started later on the same day (late evening on 12-30-20). Woke up at 5:00 am the next morning (12-31-20)with severe chills, headache and dizziness.   Felt as if I had covid all over again (was diagnosed with covid on October 12, 2020). My whole body ached and I was extremely fatigued.  All I wanted to do was sleep and I also started a slight cough. Later on in the afternoon I started to sweat profusely.  I had chills/sweats all through the afternoon and into the evening.  I did not even get out out bed until the next afternoon (1-1-21).  For 2 days afterwards I had chills/sweats and on 1-2-21 I had terrible stomach cramps and diarrhea.
This spontaneous report as received from a nurse practitioner refers to a 9 weeks old patient of unknown gender. No information on patient's medical history or concurrent conditions was provided. On 05-JAN-2015, the patient was vaccinated with the dose of LIQUID PEDVAXHIB lot # K008874 (dose, strength, route of administration and expiration date were not reported) which had temperature excursion. No information on patient's concomitant medication was provided. This is one of several reports from the same reporter. Additional information has been requested.
Pt c/o pain immediately after vaccine - gradually improved but never resolved. Then noted pain getting worse to a point cannot lift Lt arm above shoulder. Advised to see PCP on 11/11/10.
I received my first Moderna vaccine the first week of May, I haven't been able to get the second dose until now; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (I received my first Moderna vaccine the first week of May, I haven't been able to get the second dose until now) 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.    In May 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 PRODUCT DOSE OMISSION ISSUE (I received my first Moderna vaccine the first week of May, I haven't been able to get the second dose until now). At the time of the report, PRODUCT DOSE OMISSION ISSUE (I received my first Moderna vaccine the first week of May, I haven't been able to get the second dose until now) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medication information reported. No treatment medication information reported.
Chest pain started within days to weeks after 2nd dose. Didn't realize it was a concern until it kept happening. Told PCP at her physical a couple months later. Pain is brief, intermittent, sometimes stabbing, dull, or like pressure. She is not an active person so she couldn't give an acceptable description of when it happens so Cardiologist said it didn't fit "pericarditis" but more recently she has noticed that when she does try to do something active she notices the chest pain which then resolves after a brief episode.
Itchy bumps like mosquito bites. Welt like that lasted over a week.
Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Shakiness-Severe, Systemic: Tinnitus-Mild
She got her vaccine, around 9:30 Friday night she did not feel as if she would make it to bed as she felt so tired.  She went to bed, her heart rate was kind of all over the place all night long.  She wears a smart watch to monitor her heart rate, and she felt lousy when she got up.  She felt faint standing in the kitche at one point and had to sit down.  She got herself into the family room (she was alone at this time), she felt as if her heart was racing, and found out later in the day and checked the smart watch and believes at a time that she felt faint her heart rate got down to 54.  At the time that she was sitting in the family room it jumped up to 105.  She did not feel very well on Saturday.  Looking The next day she was feeling better, was able to move around the house, kept busy.  Monday night she had another terrible night, nightmare, got her feet tangled up in her bed, and has bunions on her feet, and had rested her feet together and woke up with tingling and burning pain in her feet.  She sat with her legs over the bed, she called for her husband.  It went away, she felt nauseaous and took a Lorazepam to help with the stress and nausea.  Every day she has gotten gradually better, but she don't feels particularly sharp.  She feels kind of achy, stretching twice a day and in touch with her massage therapist to get a message, and feels like she has been run over by a truck.    She did call her doctor and she was told to hydrate as much possible, she should report it to pharmacy, and she was told that she should not get the senior shot the next time.  They think that maybe the antigen was not a good thing for her to have.  She was to call them back if anything flared up.
A non-serious, spontaneous report of gave FLUMIST to a 54 year-old was received from a pharmacist, concerning a 54 year-old female subsequent to FLUMIST. There was no adverse even associated with this medication error; therefore treatment and reporter/sponsor causality assessments are not applicable and the event is considered resolved.
Headache, lightheadedness, fatigue 5 to 10 min post vaccination
Patient was given vaccine and seemed fine.  After exiting the store, patient passed out and fell on the ground.  Patient's caretaker came in to report her cousin fainted.  Pharmacy personnel went out to check on patient.  Patient was already up and sitting in the back of the vehicle.  Pharmacist asked if patient was ok and if they needed an ambulance.  Patient/caregiver declined and said they would drive home and call ambulance from there if needed.  They also stated patient has fear of needles and frequently passes out during blood draws and vaccinations.
Tightness and discomfort in chest, tightness and irritation in her throat and her lips began to swell. Eyes extremely red and watery.
Patient received vaccination 2 weeks ago. During the following weeks, patient complained of pain in shoulder when sleeping, and abducting or adducting arm. Difficulty in dressing himself. After 12 days, patient's mother called the pharmacy for the first time to inform us that patient was experiencing pain still after 2 weeks. Mother informed us that she watched immunizer insert needle, pull it out, and then reinsert it lower. She figured that the initial shot was inserted too high.  Nothing was injected during the initial injection. Mom stated patient was icing shoulder with minimal relief.
Vaccine administered at 1330.  Patient states swelling began @ 1800.  Advised by Pharmacist to take Benadryl.  Benadryl 25 mg. po ineffective.  Peri oral swelling continued, eyese reddened, short of breath.  MD advised to go to E.R.  Patient received IV medications and fluids.  12/5/08 Reviewed ER medical records of 11/17/2008. FINAL DX: allergic reaction Records reveal patient experienced throat constriction, red eyes, sinus tachycardia, chest pressure.  Exam revealed throat swelling.  D/C to home on steroids.
Right arm pain from elbow to shoulder, unable to elevate arm above shoulder with minimal swelling.  Treatment 400mg Ibuprofen Tid after food for 1 week.
positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; This is a spontaneous report from a contactable physician. A 75-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2nd via an unspecified route of administration on 02Mar2021 (Lot Number: EN6198) as single dose, dose 1st via an unspecified route of administration on 09Feb2021 (Lot Number: EL9269) as single dose for covid-19 immunisation. Medical history included afib, heart disease, hypothyroidism, hyperlipedemia, aortic valve disorders. Concomitant medication(s) included levothyroxine, omeprazole, rivaroxaban (XARELTO), rosuvastatin and flecainide. On 26Mar2021, the patient experienced flu like symptoms, fever, body aches, loss of smell and taste and weakness. On 31Mar2021, nasal swab test was done which showed SARS COV2 RNA as positive and for INFLUENZA A & INFLUENZA B as negative. There was no treatment given for the reported events. There was no covid prior to vaccination. The patient was tested for covid post vaccination. The outcome of the events was not recovered.; Sender's Comments: As it is reported that the patient had received both the doses of the vaccine within the required time interval yet the efficacy of the vaccine varies from patient to patient and can be affected by various factors. However, a contributory role of the usage of the vaccine BNT162B2 to the reported events vaccination failure and COVID-19 cannot be completely excluded.
10min p/vomited x 3;20min p/devel facial erythema & lip swelling;given epi & DPH;60min p/administer sx resolved;no cough;no dyspnea;afebrile;
Adverse Event. Child received 2 intranasal H1N1 vaccines and 2 seasonal injectable vaccines in the same day.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 29Jan2021 as dose1, single (Lot number: EL3247), in left arm, on 19Feb2021 as dose 2, single (Lot number: EM9810), in left arm, on 04Oct2021 as dose 3 (booster), single (Lot number: FF2587), in left arm and on 26Apr2022 as dose 4 (booster), single (Lot number: FK9893) at the age of 69 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Negative, notes: Negative test following completion of tx with Paxlovid; (04Aug2022) Positive, notes: Tested positive again, 7 days after completion of tx with Paxlovid. Therapeutic measures were taken as a result of vaccination failure, covid-19.
I started coughing on 11/12/2022 I tested myself for COVID-19 and the result was negative. My cough continued, so I tested myself again on 11/13/2022 and the result was positive. My symptoms progressed and I got headaches, nasal congestion, and fever. I called for a telehealth visit. I was prescribed PAXLOVID right away due to my preexisting asthma. After beginning the medication, my symptoms continued. My fever would go up and down. I treated those symptoms with TYLENOL and cough medicine. It took a full 15 days for me to test negative and I still have a bit of cough and congestion as well as having lost my voice.
On 6/27/08, my son received the 3rd doses of his Hep B and DTaP vaccines.  On 6/28/07, my son did not wake at his usual time - around 7 am.  I went into his room at 8:30 to check on him and there was vomit all over his bed.  He was very lethargic acting.  I took him downstairs and he threw up again.  I called his Dr. office and the nurse told me to give him Tylenol and bring him in.  I did not feel comfortable giving him Tylenol, as I did not want to mask his symptoms.  I monitored him and he started to improve, throughout the day.  He was able to keep lunch down and as the day progressed, perked up.
Fever of 102 and dehydration contributed to a syncope collapse early the morning after vaccination (7:15 AM  02/20/21). Just before collapsing, I experienced nausea, dizziness, confusion, weakness, and seeing all black in my field of vision. Emergency Room doctors say it was very likely related to an adverse reaction to the second Pfizer Covid vaccination. Treatment included Tylenol and Ibuprofen, rest, and fluids.
Ankle Pain - Information has been received form a pharmacist concerning a 6 year old female who was vaccinated with one dose of varicella virus vaccine live.  One week after vaccination, the patient experienced arthralgias in her ankles.  medical attention was sought.
approx. 5 minutes after injection, palms were itchy and lips felt tingly. After 30 min observation, pt returned home and noticed her lip felt tight. When she looked in the mirror, she saw one side was swollen.
This case was reported by a lawyer and described the occurrence of confusion in a 43 year old male patient who received Lyme disease vaccine recombinant OspA (LYMErix) injection for prophylaxis. A physician or other health care professional has not verified this report. On an unspeceified date, the patient received LYMErix. At an unknown time after receiving LYMErix, the patient experienced "severe joint pain, fatigue, numbness, burning, weakness, confusion, loss of concentration, and headaches" time to onset, treatment, and outcome were not reported.
My left Lymp node is still a bit swollen a week after the vaccine. Both lymp nodes were swollen but the right lymp node went down.; This is a spontaneous report from a contactable consumer, the patient. A 44-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the left arm on an unknown date in Apr2021 at 18:00 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. Medical history included shingles, varicella zoster.  The patient had known allergies to penicillin (MANUFACTURER UNKNOWN). Concomitant medications included metoprolol 25mg (MANUFACTURER UNKNOWN), omeprazole 20mg (OMEPRAZOL) and aciclovir sodium 400 (ACYCLOVIR) all from unknown dates, for unknown indications and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 03Apr2021 at 19:00, the patient experienced both lymph nodes were swollen, left lymph node is still a bit swollen a week after the vaccine. But the right lymph node went down. It was unknown, therapeutic measures were taken as a result of reported event. The adverse events didn't result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event left both lymph nodes were swollen was recovering at the time of this report.    No follow-up attempts are needed. No further information is expected.
Vaccine associated measles (Rubeola), fever X 5 days followed by morbilliform rash on face, trunk and extremities; decreased appetite and some congestion and watery eyes.
This spontaneous report as received from a pharmacist via a company representative refers to an unknown age female patient. Pertinent medical history, drug allergies or reaction were not reported. In approximately December 2013/January 2014, reported as "within the last month", the patient was vaccinated with ZOSTAVAX, lot # J005849, expiration date: 17-AUG-2014, subcutaneous. Concomitant medication was not reported. On an unknown date, the patient experienced mild local reaction at injection site. The patient developed an itchy, red, tender "knot" with swelling at site of ZOSTAVAX injection. The patient sought medical attention. The patient's symptoms resolved within 4 - 5 days. Causality was not reported. This case is linked to the same reporter MARRS# 1401USA002531 and 1401USA003341. Additional information has been requested.
severe headache; ran a 99 F low grade temperature; This spontaneous case was reported by an other health care professional and describes the occurrence of HEADACHE (severe headache) and PYREXIA (ran a 99 F low grade temperature) in a male patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (severe headache) and PYREXIA (ran a 99 F low grade temperature). At the time of the report, HEADACHE (severe headache) and PYREXIA (ran a 99 F low grade temperature) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 99 F.     The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.   For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  Patient has no immune system. No treatment information was reported.   Reporter did not allow further contact
Patient died on 2/2/2022, just 4-5 days after receiving his booster of the COVID-19 Injection from Pfizer.  He was feeling just fine that day and had gone out for his daily walk.  He had been seen by his cardiologist a week before (roughly) and was said to be doing well without any immediate concerns that would consider him at risk of a spontaneous cardiac event.