chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A small tickle feeling started in my throat Tuesday (day after). The tickle wasn't as dramatic as initial symptoms of a normal cold. Wednesday, I had significant fatigue and nasal symptoms (congestion, runny nose). I had to keep a tissue nearby. I took diphenhydramine at night. By Thursday I was coughing and still fatigued. I also couldn't think as sharply. Friday, I woke up with a headache and dizziness. In fact, my husband had to take my son to school because I felt like I was going to pass out and vomit. I felt like maybe I didn't breathe well as I slept, so I just practiced consciously breathing all day and took some generic migraine medicine (acetaminophen, aspirin, caffeine). I went to the store later and got fatigued again, feeling I was going to pass out. I went home and rested and drank lots of water despite light yellow urine (I did not feel dehydrated). By Saturday I was better and decided to exercise (jump on trampoline) for endorphins. I tolerated it well. I have felt fine since then.
Arm pain, generalized weakness, nausea, fatigue, brain fog. Tx rest, otc analgesic. Outcome: pending.
9:50 AM), 40 minutes after injection face, lips and left pinky finger got tingly (pins and needles), and throat was numb.  Symptoms persisted for 5 hours. During that time had a few minutes about 12:30  PM of hearing blockage, followed by headache. Slight tingling still persist at time of filing (5:15 PM)  I will be contacting my doctor however since I have not been able to get a hold of them yet, I have indicated no  clinic visit at this time.
Hospitalized 3/18/22-3/22/22 weakness, cough, congestion, UTI
COVID 19; COVID 19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 66 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "single functioning kidney" (unspecified if ongoing). Concomitant medication(s) included: SYNTHYROID; METOPROLOL TARTRATE. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient received other medication (Metoprolol tartrate, Synthyroid) in 2 weeks. Patient took Paxlovid as a anti viral Treatment. Patient had no allergies.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
redness and pain at the injections site; redness and pain at the injections site; swelling at the injection site.; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 66-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st December 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 9 months after receiving Shingrix, the patient experienced injection site erythema, injection site pain and injection site swelling. On an unknown date, the outcome of the injection site erythema, injection site pain and injection site swelling were unknown.   It was unknown if the reporter considered the injection site erythema, injection site pain and injection site swelling to be related to Shingrix.  Additional details were reported as follows: The patient received 1st dose Shingrix in left arm and experienced redness, pain and swelling at the injections site. The patient did not receive his second dose of Shingrix vaccine due to Covid 19 and redness, pain and swelling at the injections site. The reporter did not consent to follow-up.
This spontaneous report as received from a pharmacist via Pfizer refers to a female patient of unknown age. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date in 2009, the patient was vaccinated with PNEUMOVAX23 (dosage regimen, frequency, lot # and expiry date not reported) for prophylaxis. On an unknown date in 2009 the patient had a bad reaction to PNEUMOVAX23. The pharmacist was now concerned if she could go ahead and take PREVNAR 13. The outcome of bad reaction was unknown. The reporter did not provide the causality assessment for event with PNEUMOVAX23. Additional information has been requested.
tested postived on 11/12/2021.  Fully vaccinated. Patient c/o chills, nonproductive cough, nasal drainage. No fever, chest pain, myalgias, diarrhea, vomiting, abdominal pain or shortness of breath. Did have SOB on exertion.  Chest xray demonstrated patchy opacities bilaterally. Discharged
swelling of right leg; This case was reported by a nurse via call center representative and described the occurrence of swelling of legs in a 3-year-old male patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2019-2020 season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent 2019-2020 season at an unknown dose. On an unknown date, less than a year after receiving Influenza vaccine Quadrivalent 2019-2020 season, the patient experienced swelling of legs. On an unknown date, the outcome of the swelling of legs was unknown.   It was unknown if the reporter considered the swelling of legs to be related to Influenza vaccine Quadrivalent 2019-2020 season.  Additional case details were reported as follows: The batch number was not reported. The patient received an unspecified flu vaccine this year and experienced swelling of his right leg. The reporter consented to follow up. The vaccine was given at a different clinic.
Scab came off 4/17/03. On 4/28, intermittent "deep" ache in l.arm, shoulder, joint and muscle. Ache gradually intensified. Had 2 episodes 2 wks. apart: late June, early July. Pt.felt like she was getting her vx "all over again". No fever, no rash, no swelling or other noticeable symptoms.
Graves disease; Information has been received from Food And Drug Administration (FDA) on 17-AUG-2022.  This spontaneous report was received from a 26 years old female consumer referring to herself. The patient's concurrent condition included seasonal allergy. The prescriptions, over-the-counter medications, dietary supplements, or herbal remedies being taken at the time of vaccination included loratadine, ibuprofen and ethinylestradiol (+) etonogestrel (NUVARING). The patient had no other illness at the time of vaccination and up to one month. The patient had no chronic or long-standing health conditions.  On an unknown date, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (lot #1602284, expiration date: 26-SEP-2021; dose and strength were unknown) intramuscularly at arm for prophylaxis. On 26-SEP-2019, at 12:20, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (lot #1621934, expiration date: 29-JAN-2022; dose and strength were unknown) intramuscularly at arm for prophylaxis.  On 07-OCT-2019 (also reported as two weeks later after the second dose), at 11:00, the patient's thyroid was swollen. The regular doctor send the patient to get the thyroid scan done and blood work. Later the patient was diagnosed with Graves disease by endocrinology doctor. At the time of reporting, the patient had not recovered from the event of Graves disease. The result/outcome of the event included doctor or other healthcare professional office/clinic visit and disability or permanent damage. The patient had not had an adverse event following any previous vaccine.  The causal relationship between Graves disease and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not provided.  This report was reported as serious by agency due to disability.  As of 07-SEP-2022, all telephone attempts trying to obtain additional information has been unsuccessful.
Systemic: Dizziness / Lightheadness-Mild, Systemic: Shakiness-Mild, Systemic: Tachycardia-Mild, Additional Details: patient was later seen in minute clinic by sites NP
Post first vax, twenty minutes later, she experienced pain at the base of her head which worsened and went to the top of her head. She developed a severe headache and also chills. She vomited after taking an Advil as treatment. The information received on May 5, 2000 reported by 7:00 pm on date of vax she had a slight headache without a fever, and chills and vomiting had resolved.
no additional AE details; improperly stored vaccine administered to patient; This spontaneous report was received from a nurse and refers to a 21-year-old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported.  On 31-AUG-2020, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 0.5 ml, lot# S008151, expiry date 20-NOV-2021 (route and site of administration were not reported) for prophylaxis.  The vaccine underwent a temperature excursion of 48.39 degrees Fahrenheit (F) for 1 hour and 45 minutes. There were no previous excursions. The call was because of digital data logger. No additional adverse events were reported. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; manufactureraddress:; manufacturercity:; manufacturerstate:; manufacturercountry:; devicelotnumber: S008151; expirationdate: 20-NOV-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Very intense, frequent heart palpitations. They have lasted 8 months, but little by little, have decreased in intensity and frequency.
Patient presents to ED with difficulty breathing, coughing, and dyspnea.  Sepsis present upon admission secondary to Covid-PNA.  Patient expired on 12/28/2021 due to cadiopulmonary arrest.
Client c/o chest pressure 5 minutes after vaccination. VS stable, EKG normal, discharged home at 12:17p.m.
3pm mother verbalizes her girl feels dizziness, general weakness and nausea, vital signs 3:10 BP 85/60, pulse 74, respiration 17 spo298% 3:25pm spo2 99%, pulse 83. Girl verbalizes blurry vision and does not feel her feet. 3:30pm medical evaluation and treatment with .9nss 500ml Iv dextrose 89 mg/dl
The pt's right upper arm was red, slightly swollen, and somewhat painful. He also complained of muscle cramping and joint pain during the night. Dr suggested Tylenol or Motrin for pain and Benadryl for local inflammation and itching.
Case number PHEH2016US026941, is an initial spontaneous report received from a pharmacist on 14 Oct 2016. This report refers to a 63 year old male patient (off label use). Medical history was not reported. Concomitant medication was not reported. The patient was vaccinated with a single dose of FLUAD (batch number 165801, expiry date: Apr 2017) at a dose of 0.5 ml intramuscular on 14 Oct 2016. No adverse event was reported following this medication error (drug administered to patient of inappropriate age).
My arm had a red area from where the injection was, later that night at 10pm , it started to hurt. The pain continued on for 3 days. then the spot was about 4 inches, it continued for another 3 days. I was prescribed  Tramadol, but the pain lasted for another couple days. Also my blood sugar spiked really high 300-400 range.
Patient is a 79-year-old male who was admitted to the hospital on 11/14.  Patient has a past medical history including coronary artery disease status post CABG hypertension chronic kidney disease.  Patient had presented with generalized weakness and fatigue.  In the emergency room patient was noted to be hypoxic and COVID-19 positive.  Patient was previously vaccinated patient initially required high-flow nasal cannula non-rebreather in the emergency room due to progressive hypoxia.  Patient was admitted to the intensive care unit.  Upon admission, patient was started on varus attentive and dexamethasone for his COVID-19 pneumonia.   Patient responded with decrease FiO2 and was transition to moderate care.  After several days, patient developed progressive hypoxemia increasing FiO2 requirement.  Pulmonary was consulted.  Patient also displayed some waxing and weaning oxygen requirements.  On 12/07 patient increased respiratory distress requiring intubation.  At the time of intubation patient was noted to have aspirated gastric contents.  Following intubation patient was transferred back to the intensive care unit, A-line and central venous access were obtained.  Patient required nitric oxide and prone positioning for his profound hypoxemia additionally patient went was placed on Levophed and vasopressin.  Patient's antibiotics were adjusted to account for the aspiration.  Patient continued to require high FiO2 as well as high peep.  Patient also remained on vaso press in and norepinephrine during his ICU stay.  Patient also developed progressive acute kidney injury and ultrasound did reveal a DVT of his lap up with Dr. Extremity for which she was placed on heparin.  Patient was made previously DNR by the patient's family and upon further discussions with the patient's family patient had previously stated that he would not want to be on dialysis.  As patient has renal failure progressed without any significant improvement in his hypoxemia and O2 requirements patient was transition to comfort care by the family.  Patient expired on December 17, 2021
Narrative:  30 min after 1st covid vaccine admin. pt felt scratchy throat and throat closing. Pt sent to ER and required an epi-pen. Dose #2 contraindicated per PCP MD. Chart flagged with ADR to covid vaccine.
Fever of 100.6, full body chills and shakes, muscle pain, headache, nausea
After my 2nd vaccine shot I kept getting heat flashes, headaches, felt dazed throughout the time I got the shot at noon till I have a seizure a few hours later at work.  It took about 4 hours till I got a seizure in reaction to the 2nd covid shot.
Suspected vaccination failure; Had a horrible case / & I had the vaccine shot before; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported. The age group was not reported but was captured as adult as per vaccine indication. The patient received Shingles vaccine and experienced horrible case which lasted for 5 months. This case was considered as suspected vaccination failure as details regarding time to onset for target disease and laboratory confirmation were unknown at the time of reporting.
42 yr old active-duty pilot started experiencing fluttering sensation in his chest and would get lightheaded 3 days after second dose.  Grounded from flight duties in Jan 2022 heart monitor should A-fib with 3 episodes with one-episode max heart rate 256.  Referred to Electrophysiologist where he had a cardio ablation.  Another Holter monitor placed.  Cardiologist implanter loop recorder Dec 2022.
Swollen lymph nodes and it painful; Swollen lymph nodes and it painful; This is a spontaneous report from a contactable consumer reported for herself. A 49-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 intramuscular, administered in Arm Right on 11Apr2021 (Batch/Lot Number: EW0162) as single dose for covid-19 immunisation.  The patient medical history was not reported. The patient's concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number:ER8727) on 21March2021 Intramuscular, Right Arm for covid-19 immunisation. The patient experienced swollen lymph nodes and it painful (non-serious) on 11Apr2021 with outcome of not recovered.  The patient took paracetamol (TYLENOL), 500mg, two times in a day for treatment.  No follow-up attempts are needed. No further information is expected.
Redness, pain and itching 3.5 x 3.5 irregular area. Minimal swelling.
Severe pain in clavicle/chest region, and shooting pains down left arm to wrist. Treated with OTC pain relievers, and heat. Pain is a little lessened, but still persists to present (12 days post injection).
Post Nasal Dripping; Exposed to COVID-19 Virus; This spontaneous case was reported by a consumer and describes the occurrence of EXPOSURE TO SARS-COV-2 (Exposed to COVID-19 Virus) and UPPER-AIRWAY COUGH SYNDROME (Post Nasal Dripping) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Mar-2021, the patient experienced EXPOSURE TO SARS-COV-2 (Exposed to COVID-19 Virus). On 24-Mar-2021, the patient experienced UPPER-AIRWAY COUGH SYNDROME (Post Nasal Dripping). At the time of the report, EXPOSURE TO SARS-COV-2 (Exposed to COVID-19 Virus) and UPPER-AIRWAY COUGH SYNDROME (Post Nasal Dripping) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
3/2/15- MMR, Tdap, Meningococcal administered. 3/3/15- Patient started present with a rash. Neck bilateral arms, hands and face. Erythema, raised, borderline. 3/5/15- Rash still present, no resolution. Patient sent to Urgent Care.
pt started to feel warm all over p/45mins; husband asked nurses to come see; having chill-like feeling also; devel h/a & neckache; no fever; given DPH; 18OCT93 f/u also had vertigo & muscle spasms in both arms & upper body every 10 seconds
Mom states child had redness, swelling, heat to touch & itching. Has been giving MOTRIN. Advised to take BENADRYL as well. If symptoms worsen to call MD. Appx 2 inches in length 1 inch wide.
Patient had breakthrough case of covid diagnosed on 8/16/21.  She had received her covid vaccines on 1/29/21 and 2/26/21.  She received regencov on 8/17/21.  She was not hospitalized.
10/07/11 left thigh with swelling & rash; resolved 10/10/11.  10/11/11 right leg pain & inablility to walk; resolved 10/15/11. Parents took photos.
This literature marketed report as received from an other health professional refers to a patient of unknown age. On an unknown date the patient was vaccinated with PNEUMOVAX 23 for prophylaxis. On an unknown date the patient experienced chest blisters and potential toxicity. The outcome of chest blisters and potential toxicity was unknown. The reporter considered chest blisters and potential toxicity to be related to PNEUMOVAX 23. This is one of several reports derived from the same literature (linked reports MARRS # 1709USA000317, 1709USA000318, 1709USA000319). Sender's Comments: US-009507513-1709USA000317: US-009507513-1709USA000318: US-009507513-1709USA000319.
Client presented to clinic for second dose on 5/2/21. Second dose was scheduled for 5/9/2021. Dose was received early. Per guidelines, client should have received second dose as early as  5/5-5/9.
Patient having breathing problems after injection; Chest tightening after injection; Upper lip swelling; This spontaneous case was reported by a health care professional and describes the occurrence of DYSPNOEA (Patient having breathing problems after injection), CHEST DISCOMFORT (Chest tightening after injection) and LIP SWELLING (Upper lip swelling) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DYSPNOEA (Patient having breathing problems after injection), CHEST DISCOMFORT (Chest tightening after injection) and LIP SWELLING (Upper lip swelling). At the time of the report, DYSPNOEA (Patient having breathing problems after injection), CHEST DISCOMFORT (Chest tightening after injection) and LIP SWELLING (Upper lip swelling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product information was not provided. Treatment medication was not provided by reporter.   Most recent FOLLOW-UP information incorporated above includes: On 20-Jul-2021: Follow-up received on 20-JUL-2021 and contains Non-significant information
Flu-like symptoms; This case was reported by a nurse via call center representative and described the occurrence of influenza-like symptoms in an unspecified number of adult patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was unknown.   It was unknown if the reporter considered the influenza-like symptoms to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not applicable. The age group was not reported but it was selected as an adult as per the vaccine indication. The nurse stated that the other patients have reported flu like symptoms after Shingrix, just not to the same severity. The nurse granted permission for safety to follow up. This case has been linked with US2019142314, reported by same reporter.
Information has been received from a physician concerning a female child (age not reported) who was the daughter of one of the reporting physician's patients. On unspecified dates, the patient was vaccinated with a first, second and third 0.5 mL dose of Gardasil at her pediatrician's office. Subsequently the patient experienced pain after each of her three doses of Gardasil, progressively getting worse each time. After the third dose, the patient also experienced nausea and had to stay home from school. Subsequently, the patient recovered from pain and nausea. No additional information is expected.