chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report from a contactable consumer. This 62-year-old female consumer reported (for herself). A 62-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN6202 and Expiration Date not reported) via an unspecified route of administration on 02Mar2021 as 1st dose, single dose for COVID-19 immunization. The patient medical history included Blood pressure high from unspecified date to unspecified date. The patient concomitant medications included atenolol taken for blood pressure high from Unspecified date to Unspecified date. The patient reported that, she think that she was having side effects from the first COVID-19 vaccine. The patient had the shot on Tuesday, on Wednesday she was fine. On Thursday 04Mar2021, the patient reported that her chest started to feel like, her chest muscles were tired, and It was hard to tell whether it her my muscles. The patient thought she pulled a muscle or something. So, the patient did not think anything of it. On Friday, it got a little stronger and by yesterday, the patient upper chest felt like she had an upper respiratory infection, but the patient had no fever. The patient was able to breath. The patient reported, it hurts quite a bit for her to take a deep breath. The patient had constant aching and pain in the upper chest, it feels like her chest was being punched and the patient thought she was not positive, but the patient think that her lymph nodes were swollen. The patient reported that, it appears like every day, were little stronger. The patient agreed that events have worsened. The patient asked that, was there something that was expected to get worse or get a little bit better and How long this will last. The patient signed up for the disease safe with CDC. All this is in just to report that, she thought she would be given some insight or something. The patient asked Is there something that is expected to get worse or get a little bit better and How long this will last for. Consumer was informed about Pfizer Medical Information. The outcome of events was not resolved. No follow-up attempts are possible. No further information is expected.
No adverse event; Patient became pregnant after receiving the first dose of the Moderna Covid-19 vaccine; This spontaneous prospective pregnancy case was reported by a patient family member or friend and describes the occurrence of MATERNAL EXPOSURE BEFORE PREGNANCY (Patient became pregnant after receiving the first dose of the Moderna Covid-19 vaccine) and NO ADVERSE EVENT (No adverse event) in a 32-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.  On 21-Aug-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 21-Aug-2022, the patient experienced MATERNAL EXPOSURE BEFORE PREGNANCY (Patient became pregnant after receiving the first dose of the Moderna Covid-19 vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). On 21-Aug-2022, MATERNAL EXPOSURE BEFORE PREGNANCY (Patient became pregnant after receiving the first dose of the Moderna Covid-19 vaccine) had resolved. At the time of the report, NO ADVERSE EVENT (No adverse event) outcome was unknown.   The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   Concomitant and treatment medications were not reported.  Patient received her second Moderna Covid-19 vaccine today (at the time of reporting) and was told that she had to start the series all over again and that today was her first dose.  Company Comment: This spontaneous case concerns a 32-year-old female patient with no medical history reported, who experienced No adverse event after receiving the first dose of mRNA-1273 vaccine. Maternal exposure before pregnancy was reported in this case as patient became pregnant after receiving the first dose of the mRNA-1273 vaccine. Last menstrual period and estimated date of delivery were not provided. No details of clinical course, lab reports or treatment received was available in the report. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2022-669156 (Patient Link).; Sender's Comments: This spontaneous case concerns a 32-year-old female patient with no medical history reported, who experienced No adverse event after receiving the first dose of mRNA-1273 vaccine. Maternal exposure before pregnancy was reported in this case as patient became pregnant after receiving the first dose of the mRNA-1273 vaccine. Last menstrual period and estimated date of delivery were not provided. No details of clinical course, lab reports or treatment received was available in the report. The benefit-risk relationship of mRNA-1273 is not affected by this report.
A non-serious spontaneous report of administration of expired FLUMIST was received from a registered nurse concerning an approximately ten-year-old male patient. Neither relevant medical history nor concomitant medications have been reported for this patient. On 05-Jan-2010, the patient received FLUMIST (expiration date 31-Dec-2009). There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the events are considered resolved.
Patient given Moderna 0.5mL dose for ages 6-11 years old. The patient is 5 years, 4 months old. He should have received 0.25mL for ages 6 months-5 years. Patient's father notified.
whole body starting aching and she had to lay down; delayed dose; Pain in arm; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (delayed dose), PAIN IN EXTREMITY (Pain in arm) and MYALGIA (whole body starting aching and she had to lay down) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 035C21A and 031B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Jun-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (delayed dose) and PAIN IN EXTREMITY (Pain in arm). On 02-Jun-2021, the patient experienced MYALGIA (whole body starting aching and she had to lay down). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. On 01-Jun-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (delayed dose) had resolved. At the time of the report, PAIN IN EXTREMITY (Pain in arm) outcome was unknown and MYALGIA (whole body starting aching and she had to lay down) was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient was also using a heating pad.  No relevant concomitant medications were reported.    This case was linked to MOD-2021-200455 (Patient Link).
Began wheezing, cough, palpitations. initially. Progressed to fever, chills and shortness of breath and extremely rapid heart beat. Temperature taken at 5:35PM was 102.2F.
Body Aches, Headache, Chills, Loss of appetite.  No measured fever. Symptoms started ~12 hours after second vaccine.  Symptoms last for ~12 hours
COVID 19 Pfizer dose given beyond use date.  Pt developed itchy bumps over her arms one week after receiving vaccine.  Pt was given Benadryl.  Bumps resolved after one week.  Pt recovered and is back to baseline
HEADACHE, EXCESSIVE FATIGUE, NAUSEA,LEG ITCHING, LEG BRUISING, LEG PAIN
Fever CHILLS, FEVER, SORE THROAT, MSUCLE PAIN, BAODY ACHES, LEG PAIN. LT LEG SWELLING AND PAIN  Narrative: 11/18 CHILLS, FEVER, SORE THROAT, MSUCLE PAIN, BODY ACHES, LEG AIN, LRT LEG SWELLING PAIN WENT TO ER  11/22 TED HOSE AND PAIN MEDS.
pt recv vax 9SEP95 & 5FEB98 pt devel chickenpox, approx 75-100 lesions;
Large golf ball sized knot to left deltoid - at injection site. Knot is warm to touch, red, tender. Unknown is knot is hematoma, abscess or cellulitis at injection site. Symptoms started x 24 hours after injection. Arm was sore after shot but knot developed approximately 24 hours later.
This spontaneous report was received from a certified medical assistant, referring to an unspecified number of patients. Ages, genders, medical history or concurrent conditions were not reported. Since on an unknown date, an unspecified number of improperly stored doses of PROQUAD (lot # L031600, expiration date 18-FEB-2017) were inadvertently administered to an unspecified number of patients. No adverse effects have been reported. The reporter refers that was not product quality complaints involved. This is one of two cases from the same reporter. Additional information has been requested.
MEMORY LOSS; DISORIENTATION; EYE PAIN; FEELING WEIRD; FEVER; VERY INTENSE HEADACHES/ PRESSURE IN THE HEAD; This spontaneous report received from a patient concerned a 32 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included non smoker, and non alcohol user, and other pre-existing medical conditions included the patient had no known drug allergies, drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, expiry: UNKNOWN) dose was not reported, administered on 22-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 23-MAY-2021, the subject experienced memory loss. On 23-MAY-2021, the subject experienced disorientation. On 23-MAY-2021, the subject experienced eye pain. On 23-MAY-2021, the subject experienced feeling weird. On 23-MAY-2021, the subject experienced fever. On 23-MAY-2021, the subject experienced very intense headaches/ pressure in the head. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from eye pain, and fever on 24-MAY-2021, had not recovered from very intense headaches/ pressure in the head, disorientation, and memory loss, and the outcome of feeling weird was not reported. This report was non-serious.; Sender's Comments: V0 Medical assessment comment not required as per standard operating procedure as the case assessed as non-serious.
Felt a wave of heat from her neck to stomach 3-4 times.  118/66b/p  pulse 62 PS02 100% Respirations even and unlabored, skin pink warm and dry.  No signs of distress. Client monitored for 30 minutes then released.  Informed to seek medical attention if any further problems.
Very harsh dysrhythmia; Parkinson's symptoms got worse with joint contractions, stiffening, and confusion; Napping more; Blood pressure has been haywire, sometimes going high and sometimes low; A spontaneous report was received from a consumer, who was also the daughter of a 93-year-old male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced a very harsh dysrhythmia (arrhythmia), Parkinson's symptoms got worse with joint contractions, stiffening, and confusion (Parkinson's disease); he has been napping more than before (somnolence), and blood pressure has been haywire, sometimes going high and sometimes low (hypertension, hypotension).  Medical history, as provided by the reporter, included COVID in July 2020 from which he fully recovered, slight dysrhythmia, Parkinson's (tremors only), and slightly elevated blood pressure.  The reported stated the patient's baseline health had been pretty good and he was usually mobile, active, cognitive, and had speech.  Concomitant medications included carbidopa monohydrate (+) levodopa, losartan, beta blocker (unspecified), and liquid morphine.    On 20 Jan 2021, one day prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 (lot number: 028L20A) intramuscularly in his right (dominant) arm for prophylaxis of COVID-19 infection.  On 21 Jan 2021, around 2 pm, the patient had "a very harsh" dysrhythmia and his Parkinson's symptoms worsened with joint contractions, stiffening, and confusion.  He had also been napping more than before.  Since getting the vaccine, his blood pressure "has been haywire", sometimes going high and sometimes low.  Treatment information was not provided.  The action taken with mRNA-1273 in response to the events was unknown.  The outcome of the events, a very harsh dysrhythmia, Parkinson's symptoms got worse with joint contractions, stiffening, and confusion; napping more than before, and blood pressure has been haywire, sometimes going high and sometimes low, were considered not recovered/not resolved at the time of this report.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Certified immunizer gave a 14-year-old patient 2 doses of 0.3ml COVID-19 Pfizer vaccine, which equals 0.6ml total at around 3:25pm. Reason being that pharmacist used 3ml syringe and she assumed that nothing was in the syringe. before double checking with the pharmacist, she gave the patient a second dose. Immunizer informed me afterwards and I contacted my manager and my district manager and the company's customer liability line submitted claim # 302176236350001. also spoke to department of health and gave her the details of what happened.
7-28-15 started fever 6:00-6:30 pm  after receiving MENACTRA that morning 100? still running fever 100.4 and sore throat next AM. 7/29/15 Rx with ZITHROMAX for pharyngitis.
Pt to ED 9/11 C/C of N&V with diarrhea and fatigue with body aches x 2 days. Pt COVID+ 9/11. 9/12 Patient complains of no pain or discomfort at this time, IV remdesivir started. 9/13 Pt A&OX4, denies pain, or any discomfort. 9/14 pt A&OX4, denies pain,sob, or discomfort. 9/15 pt sepsis BPA firing,WBC 20.6 today and trending down, pt otherwise stable. 9/16 pt discharged.
8 days after the vaccine was given, a rash began to form around the injection site. At the time of the injection, a bandaid was not placed over the injection site. due to concern for infection, medical treatment was recommended with hydrocortisone and benadryl creams. As of today, rash is stabilizing, slightly worse
This case was reported by a consumer via call center representative and described the occurrence of tremor in a 82-year-old male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX (1st dose received on unknown date). On 11th March 2019, the patient received the 2nd dose of SHINGRIX. In March 2019, less than a week after receiving SHINGRIX, the patient experienced tremor, general body pain, diarrhea, movement disorder, weakness, difficulty sleeping, injection site pain and dizziness. On an unknown date, the outcome of the tremor, general body pain, diarrhea, movement disorder, weakness, difficulty sleeping, injection site pain and dizziness were recovered/resolved. It was unknown if the reporter considered the tremor, general body pain, diarrhea, movement disorder, weakness, difficulty sleeping, injection site pain and dizziness to be related to SHINGRIX. Additional case details were provided as follows: The patient received the dose of SHINGRIX in his left arm. The patient had experienced shakiness all over the body, body ache, diarrhea, trouble moving, weakness, trouble sleeping, pain at injection site and dizziness. All of this symptoms lasted for about 4 days and he has now recovered. The reporter has been given consent for follow up. This case has been linked to US2019047144 reported by same reporter (Husband).
injection arm suffer swelling the first days after injection, then resolve.  several weeks later develop numbness to hand of same injected arm.  present to UC on 2/22/21 and receive burst of steroids
Blister at injection site. Band Aid brand Curad Latex fee SANS free cloth Band Aid.
After receiving the pneumovax 23 the patient complained of pain, swelling, redness (syptoms of cellulitis)of the arm that was injected. The physician put the patient on antibiotics
Patient received Tdap vaccine on 4/9/19 at Clinic OB. Patient started having pain following day in the right arm with redness (16x10cm) warm to touch. Vaccine was not given in proper site. Way lower then deltoid, most likely give Sub Q. Pt followed up at our clinic since OB was gone. Patient was advised by Dr. to continue with ice and Tylenol as needed. A border was drawn around inflamed area. (App 16x10 cm). Patient will call us back if redness continues to spread. Clinic was contacted about reaction. Also advised to educate on proper admin site education.
Patient received Moderna instead of Pfizer as her second COVID vaccine.  Patient denied any distress/issues after vaccination.  Vitals wnl at 1246.  Patient went home in no apparent distress.
Initial vaccination failure in inflammatory bowel disease patients; 149 patients with inadequate baseline titers; Overall, 58.4% (n = 87/149) of patients received 1 or 2 sequential HBV revaccination doses within a 6- month time period, and 41.6% (n = 62/149) of patients received 3 sequential revaccination doses during a 12-month time period; Information was received from the authors in a published literature article titled as stated below. The aim of this article was to analyze the association between additional vaccination doses and HBsAb seroconversion in infIammatory bowel disease (IBD) patients. This case concerns 149 unspecified patients of unknown genders and age. This retrospective cohort study of patients seen in a large tertiary care facility from 2000-2014. Inclusion criteria: age >=18, diagnosis of Crohn's disease (CD) / ulcerative colitis (UC), prior vaccination history/presence of >= 1 +HBsAb level <10 IU/l, follow up HBsAb level after re vaccination. Patients were separated into study arms based on the number of additional vaccine doses received: 1 and 2 (within 6 months) or 3 (within 12months). Follow-up serum HBsAb, demographic info and IBD medications received in the 6 months prior to titer measurements were reported. Seroprotection was defined as HBsAb >= 10 IU/l.   On unknown dates, the patients were vaccinated with hepatitis b vaccine (manufacturer unknown), lot number, expiration date, dose and route were not reported, for prophylaxis. On unknown date, the patients showed inadequate baseline titers (vacination failure): 63 then received 1 dose, 25 received 2 doses, 61 received 3 doses. Following 1, 2 and 3 doses, average follow-up titers were 122.8, 55.1 and 263.8 IU/l, respectively. Following 1, 2 and 3 doses, 41.3, 40 and 62.3%, respectively, developed HBsAb 10 . Patients exposed to immunosuppressive therapy within 6 months of titer measurement were significantly less likely to seroconvert after any number of additional vaccinations.  Follow up information was received on 25-APR-2019 to this previously non-valid case, from the authors in a published literature article titled as stated below, regarding 68 male patients from 149 patients in study cohort.  It was also reported that unspecified number of male patients (of a total of 87 out of 149 patients, previously reported as 88) received 1 or 2 sequential HBV revaccination doses within a 6-month time period, and unspecified number of male patients (of a total of 62 out of 149 patients, previously reported as 61) received 3 sequential revaccination doses during a 12-month time period.    This is one of several reports received from the same reporter.  Sender's Comments:  US-009507513-1710USA010440:
Severe headache; malaise; fatigue; syncope and collapse - orthostatic hypotension; Orthostatic hypotension; This is a spontaneous report from a contactable nurse (patient). A 49-year-old female patient (non-pregnant) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685), via an unspecified route of administration on 18Dec2020 at single dose at right arm for covid-19 immunization. Medical history included chronic fatigue, hypothyroidism, allergic rhinitis from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine, patient didn't receive other medication within 2 weeks of vaccination. The patient previously took promethazine hydrochloride (PHENERGAN) and experienced allergies: phenergan. After 1st dose, patient had severe headache for five days, malaise, fatigue on 19Dec2020 09:45 PM, day 6 syncope and collapse - orthostatic hypotension in Dec2020. The adverse events resulted in emergency room/department or urgent care. Adverse events treatment included CT head, carotid doppler, echocardiogram, lab work. It was unknown if the patient was not diagnosed with COVID-19 prior to vaccination. Covid test type post vaccination included nasal swab on 24Dec2020: negative. Patient received second dose of bnt162b2 (lot number: el0142) on 08Jan2021 10:00 at single dose at left arm for covid-19 immunization. Outcome of events was recovered on unspecified date.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of syncope, orthostatic hypotension and other events  due to temporal relationship.  However,  the events may likely possibly  represent concurrent medical conditions in this patient.  There is limited information provided in this report.  Additional information is needed to better assess the case, including complete medical history, diagnostics including head CT/MRI, counteractive treatment measures and concomitant medications.  This case will be reassessed once additional information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Headache (a couple hours after injection both times), Tired (a couple hours after injection both times), and Rash (various places, 2 days after each injection, lasted for over a week from first injection, second injection is also causing small rashes in various places already- similar to systemic poison ivy that I had this past summer)
Patient lost consciousness momentarily approximately five minutes after receiving the vaccination.  Fell to the floor from seated position whereupon we immediately called 911, went to him and tried to verbally arousing him, which was immediately successful. We then assisted patient to a seated position and assessed him. Patient was profusely perspiring , had a strong pulse, was still seemingly out-of-it. His skin was pale and clammy and respirations slowed as he seemed to lose consciousness. A sheriff deputy happened to be on-site and she assisted patient as retrieved an Epi-Pen. Upon the arrival of Epi, patient had made a significant improvement - he became lucid and respiration increased with improved consciousness.  Patient said he was hot, wanted cold water which we gave him. Patient was alert and asking questions as EMS arrived after approximately 5-10 minutes and performed assessment and checked vitals - which were apparently in normal ranges at that point. Patient answered EMS questions and stayed for a short while before driving himself home. We requested he call the pharmacy when he arrived at home - which he did, saying he felt ok, but was sore apparently from the fall from his seat.