chrisvoncsefalvay/vaers-outcomes huggingface dataset:
fever of 105F; chills; severe headache; arm pain; This is a spontaneous report from a Pfizer-sponsored program from a non-contactable healthcare professional (HCP).  A 70 year-old female patient (pregnancy information not reported) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, on 18Dec2020 (at the age of 70 years-old) as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Prior to receiving the vaccination it was not reported if the patient had been tested for COVID-10. It was also not known if she received any other vaccinations in 4 weeks or other medications in past 2 weeks. On 18Dec2020, the patient received the first dose of the COVID-19 vaccine and had arm pain that lasted for a few hours at that time. Seventeen days post first vaccination (approximately 04Jan2021), she developed a fever of 105F, chills and severe headache which have now resolved.  She wanted to know if she should get the second vaccine in series given her side effects. it was not reported if the patient was hospitalized or treated for the events.The clinical outcome of the events of arm pain, fever of 105F, chills and severe headache was recovered on an unspecified date. It was not reported if the patient was tested for COVID-19 after receiving the vaccination.  Information about batch/lot number has been requested.
Welt on left arm; Tinnitus in right ear; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6204) via an unspecified route of administration in the arm left on 10Mar2021 at 11:00(at the age of 52-year-old) as a single dose for COVID-19 immunisation. Medical history included high cholesterol and triglycerides (triglycerides high). Concomitant medications included atorvastatin calcium (LIPITOR), fenofibrate (MANUFACTURER UNKNOWN), fexofenadine hydrochloride (ALLEGRA), fluticasone propionate (FLONASE) and beclometasone dipropionate (QVAR) for unknown indication from an unspecified date. The patient had no known allergies to medications, food or other products. The patient previously received first dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration on an unknown date in 2021 (at the age of 52-year- old) as a single dose for COVID-19 immunisation. 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 vaccination. On 12Mar2021, the patient experienced welt on left arm and tinnitus in right ear. The clinical outcome of the event welt on left arm and tinnitus in right ear was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Apparent COVID. General feeling of malaise, sore throat, headache, mild cough, low fever.
Dizziness; Headache right side and back right side; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness) and HEADACHE (Headache right side and back right side) 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 an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced DIZZINESS (Dizziness) and HEADACHE (Headache right side and back right side). At the time of the report, DIZZINESS (Dizziness) and HEADACHE (Headache right side and back right side) outcome was unknown. Not Provided          Concomitant medication history not provided. Treatment information was unknown.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Follow up received on 25-MMY-2021, contain non significant follow up information. NNI
Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Hypotension-Severe
Severe vertigo, headache for 2 weeks. Headache persisted and was recurrent for about 2 months. It was bad enough to miss school over 6 weeks. I hope there is no residual problem. Per annual report-She got better after 2 months. But she no longer function at schol. Poor memory. Poor concentration.  Chronic daily headache and dizziness.
24 hours after injection: Patient noticed redness to Left upper arm. 48 hours after injection; redness to Left arm got worse & burning sensation started. 72 hours after injection: burning sensation  is getting worse.  Treatments: Prednisone 40 mg & Zyrtec 10mg. RX Monodox 100mg
This spontaneous case, initially received on 01-Sep-2016, was reported by a health professional and concerns a 53-year-old male patient. Weight: not provided; Height: not provided. Administration of company suspect drug(s): The patient received AFLURIA from 31-AUG-2016 to 31-AUG-2016. Dose regimen: 0.5 ml 1 time dose, Route of administration: Intramuscular. Batch number: WT54006. No additional suspect drugs. Special circumstances: On 31-Aug-2016, the patient was administered AFLURIA that reached 47F for 8 hours - no adverse event. The outcome was reported as unknown. Reporter comments: The reporter considered the event as non-serious (medication error).
Pt received flu and covid vaccine together; approx 8 minutes later pt complained of lightheadedness and nausea. Provider was immediately notified; pt was lowered to the floor and legs were elevated and a ice pack was placed behind his neck. Pt v/s were within normal limits
Round 3x3 inch rash - mild pain but itchy rash continuing for 2nd week.  Appeared day after injection - was fiery red and has grown in size to 4 x 4 but less red.  Very Itch like having poison ivy.
Narrative:  Patient received second dose of Pfizer COVID-19 vaccine on 9/9/21. Reportedly she developed palpitations 2-3 days after the immunization. Palpitations lasted 1 to 1.5 weeks and occurred every 5 minutes for several hours. The patient felt that her breath was taken away for a few moments. Of note, she appears to have a history of arrhythmias and was on a Zio Patch even prior to initiating the vaccine series. She reports compliance with her metoprolol. She denies drinking energy drinks or caffeine at the time. The palpitations self resolved.
Discharge Provider:  DO Primary Care Provider:  MD Admission Date: 11/4/2022 Discharge Date: 11/10/2022  Covid Positive Date: 11/4/2022 Clinical Narrative: This is a 96-year-old gentleman with dementia who is cared for at home by h his daughter.  Patient had not been feeling well and had cough and chest congestion, and the daughter her tested him for COVID which was positive, and followed his pulse oximetry at home and had intermittent mild hypoxemia noted.  His brought to the emergency room where his workup revealed pulse oximetry revealed variable episodes measurements of pulse oximetry less than 90%., and there were no pulmonary infiltrates.  He was started on dexamethasone and remdesivir.  He subsequently developed increased agitation and confusion thought to be secondary to the corticosteroids versus sundowners delirium.  This led to discontinuation of the dexamethasone, which improved but did not resolve the restlessness.  He also developed severe urinary frequency urinating about every 15 minutes.  He had variable  postvoid residuals, but not greater than 160 mL.  Dr. was consulted and recommended against the bladder antispasmodics and alpha blockers due to his age and dementia.  Subsequent urine analysis and culture demonstrated Enterococcus urinary tract infection turn culture positive on 11 10 which was the day of discharge.  He received 1 dose of amoxicillin prior to discharge.  Another measure that was taken to decrease the urinary frequency was a reduction in his Bumex dose from 1 mg daily to 0.5 mg daily for his chronic congestive heart failure.  Due to his restlessness and tendency toward agitation, he was started on Seroquel which he will be discharged on.   Patient will return home under the care of his daughter, with home health care.
This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Pin marks all over her body, shoulder, legs) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037K20A and 024M20A) for COVID-19 vaccination.     Concurrent medical conditions included Glaucoma and Heartburn. Concomitant products included LATANOPROST for Glaucoma, OMEPRAZOLE for Heartburn, APIXABAN (ELIQUIS) for an unknown indication.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Jan-2021, the patient experienced PARAESTHESIA (Pin marks all over her body, shoulder, legs). On 16-Jan-2021, PARAESTHESIA (Pin marks all over her body, shoulder, legs) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No treatment information was provided.   This case was linked to MOD-2021-044828 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 13-May-2021: NNI were not provided.
Mom called on 10/28/00 complaining of child's injection site was red and warm; inspection by MD; stated no fluctuance. On 10/30/00, mom calls again stating it is worse. Area was warm, red and with fluctuance; MD performed I & D, packed with sterile gauze and was given treatment and antibiotic (oral).
I had a slight fever (lower than 100'), body aches, fatigue, and felt nauseous.  I felt like I had the flu.
Note   Pt called with Temp of 103 and chest congestion with cough.  Difficulty getting anything fluids or food in .  C/o some SOB.  Advised ER evaluation and pt in agreement.  Refuses ambulance but will have family take her in. ED to Hosp-Admission Discharged 9/9/2021 - 9/12/2021 (3 days) Hospital   - COVID-19  Presenting Problem/History of Present Illness/Reason for Admission Hypoxia [R09.02] COVID-19 [U07.1]     Hospital Course 72-year-old female with a past medical history of hypertension presented to the emergency department with shortness of breath, arthralgias/myalgias, fevers secondary to Covid pneumonia.  Patient is vaccinated, received 2 doses of the vaccine with her last dose being in April 2021.  She lives by herself, over the past 2 days she began developing worsening fatigue and shortness of breath.  This is also worsened by her fibromyalgia, anxiety and depression.  Checked temperatures at home when she had a fever up to 103 °F, she was self treating with Tylenol.  She called her PCP who recommended she go to the emergency department for further work-up.  In the emergency department, COVID-19 test was positive on 9/9/2021, x-ray showed infiltrates as well as possible linear infiltrate which is consistent with scarring from previous pneumonia.  She admitted to the hospital for hypoxia and COVID-19 pneumonia.   1.  Hypoxic respiratory failure, COVID-19 infection Patient was admitted to the hospital and started on oxygen, given her hypoxic respiratory failure she was started on Decadron and Remdesivir.  Her oxygen was slowly weaned, she was stable on room air but will require oxygen at discharge with ambulation.  Her shortness of breath and generalized weakness and fatigue significantly improved during her hospitalization.  On her day of discharge, again she was stable on room air but did have significant shortness of breath with ambulation, will be sent home with 2 L nasal cannula with ambulation.  Also have bronchodilator therapy as well as send a short course of Decadron as an outpatient.  She will follow up with PCP in 1 week who could help manage her oxygen as an outpatient.   2.  Hypertension, hyperlipidemia Pressures are stable during hospitalization, can continue lisinopril 20 mg daily, will decrease amlodipine 5 mg daily given some lower blood pressures while hospitalized.  Continue Crestor 10 mg daily.   3.  Bradycardia Patient bradycardia during hospitalization, she is asymptomatic.  Possibly secondary to remdesivir which she was on for her COVID-19 infection.  She has significant part of her symptoms, was asymptomatic, stable for discharge.   On day of discharge, her symptoms significantly improved from time of admission.  Oxygen is weaning down, inflammatory markers trending down, and generalized weakness and fatigue has improved.  She is evaluated by PT/OT who cleared her for discharge home.  Will be sent home with oxygen with ambulation, oral Decadron, Tessalon Perles, albuterol inhaler.
1/26/2021 to 1/27/2021  Body aches, nausea, diarrhea, abdominal cramping,  1/28/2021  mild facial edema/periorbital & upper lip
After the vaccines lost temperature they were administered; A spontaneous report was received from a healthcare professional concerning a 77-year-old, White female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the event, after the vaccines lost temperature they were administered.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 11 Jan 2021, a refrigerator in a vaccine clinic lost power and rose up to room temperature overnight. At approximately 9 p.m., the vaccines inside the refrigerator reached room temperature.  On 12 Jan 2021, after the vaccine lost temperature, the patient received their first of two planned doses of mRNA-1273 (Lot number: 027L20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.  No treatment information was provided.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.  The event, after the vaccines lost temperature they were administered, was considered resolved on 12 Jan 2021.; Reporter's Comments: This case concerns a 77-year-old female patient who received their first of two planned doses of mRNA-1273 (Lot unknown), reporting Out of specification product use.
Patient had severe pain in stomach on Friday 2nd July, 3 days after 2nd shot of Pfizer and on July3 had to be admitted to hospital for appendectomy. His surgery was on 4th of July
Soreness in left arm, chills, fatigue, dull headache  starting about 3-4 hours after injection and lasting through the night.
Patient experienced shoulder pain and weakness in legs that extended day after the faccination. After 10 days of vaccination, patient pain/discomfort has subsided but is still experiencing weakness in the legs.
Received Moderna COVID-19 vaccine on 12/29/20. Experienced injection site tenderness, headache, and sinus congestion after injection. Over the weekend (1/2/21-1/3/21), experienced dizziness/vertigo upon awakening. The dizziness occurred intermittently throughout the hours of the days. On 1/5/21, experienced intermittent vertigo many times while standing or sitting at work. Attending physician was notified. Physician recommended employee see PCP follow-up to rule out additional causes (may be multifactorial).
arm hurts; worried about second shot; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm hurts) and TENSION (worried about second shot) in a 98-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (arm hurts) and TENSION (worried about second shot). At the time of the report, PAIN IN EXTREMITY (arm hurts) and TENSION (worried about second shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment and concomitant medications were not provided by reporter.
Immunization DTAP 0.5 mL administered instead of T-DAP 0.5 mL.  No side effects reported.
19APR93 that noc t103.7, lethargic not eating APAP given; spoke to pvt MD: 20APR93 915 t97.6 cont to be lethargic & cont APPA; 2PM t102.3-discussed sponge baths cont APAP; 21APR93 t100.9-walking around generally improved cont APAP;
slept a lot; been tired for several months; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSOMNIA (slept a lot) and FATIGUE (been tired for several months) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Allergy (takes medications for severe allergies) and Lung disorder (takes Albuterol to help the lungs). Concomitant products included ALBUTEROL [SALBUTAMOL] for Lung disease.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced HYPERSOMNIA (slept a lot) and FATIGUE (been tired for several months). At the time of the report, HYPERSOMNIA (slept a lot) and FATIGUE (been tired for several months) outcome was unknown.            Patient reported that everybody the patient knew got tired from the Covid-19 vaccines and one friend received the Moderna Covid-19 vaccine.  No treatment medications were reported.  Company comment-This case concerns a 67 year-old, female patient with concomitant use of salbutamol, who experienced the non serious unexpected AESI event of hypersomnia. The event occurred at an unknown date after the second dose of Moderna COVID-19 vaccine. The rechallenge was not applicable, as the event was reported exclusively after the second dose. The use of concomitant medication salbutamol, negative rechallenge remain a confounder. The benefit-risk relationship of Moderna COVID-19 vaccine is not affected by this report.   This case was linked to MOD-2021-368011 (Patient Link).; Sender's Comments: This case concerns a 67 year-old, female patient with concomitant use of salbutamol, who experienced the non serious unexpected AESI event of hypersomnia. The event occurred at an unknown date after the second dose of Moderna COVID-19 vaccine. The rechallenge was not applicable, as the event was reported exclusively after the second dose. The use of concomitant medication salbutamol, negative rechallenge remain a confounder. The benefit-risk relationship of Moderna COVID-19 vaccine is not affected by this report.
large coalescent urticarial areas inner thighs & scattered erythematous large red areas extremities & fingers appeared 8-9 days s/p hepb V vax;rx Claritin syrup;
The following ady, i have  headaches on the back part of my head comes and goes with Tylenol.; The body ache comes and  goes with Tylenol; Dizziness lingers for7 days now. Even with pain reliever.; Lightheadedness lingers for7 days now. Even with pain reliever.; Headaches is worsening; I have chills on the 30th hour. The following day, I have mostly occasional chills; I have fevers on the 30th hour; This is a spontaneous report from a contactable consumer, the patient. A 57-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 06Apr2021 at 14:30 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had known allergies to latex. Concomitant medications included lisinopril (MANUFACTURER UNKNOWN) and atorvastatin (MANUFACTURER UNKNOWN) indicated for unknow, on unknown date and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the  left arm on 15Mar2021 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient had not been diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 07Apr2021 at 15:45 the patient experienced chills and fevers on the thirty hours. On 08Apr2021, the following day, patient experienced mostly headaches, body aches and occasional chills. The body ache and headache on the back part of head comes and goes with tylenol. The dizziness and lightheadedness lingers for seven days, even with pain reliever, headaches was worsening. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of occurred events and included treatment with tylenol and even with pain reliever. The clinical outcome of the events chills, fevers, headaches, body aches, dizziness, lightheadedness and headaches was worsening was not recovered at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
several pt @ this facility devel inj site rxn characterized by redness & swelling p/vax;pt recovered w/in 4-5 days;
Patient arrived at clinic to receive Kinrix. Pediarix was administered resulting in a fourth, and unneeded dose of Hepatitis B.  Parent of patient was notified and questions were answered.
This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INDURATION (There's a lump in it), VACCINATION SITE SWELLING (swelling at the injection site) and VACCINATION SITE ERYTHEMA (Redness at the injection site) 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 January 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 UNK. On an unknown date, the patient experienced VACCINATION SITE INDURATION (There's a lump in it), VACCINATION SITE SWELLING (swelling at the injection site) and VACCINATION SITE ERYTHEMA (Redness at the injection site). At the time of the report, VACCINATION SITE INDURATION (There's a lump in it), VACCINATION SITE SWELLING (swelling at the injection site) and VACCINATION SITE ERYTHEMA (Redness at the injection site) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant medications taken by the patient were not provided. Treatment activities for event was unknown.; Sender'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.  Further information have been requested.
patient called roughly 1 hour after getting vaccine indicating she was blowing her nose when it started to bleed. It was a consistent flow and had been going on for 5 minutes before calling the pharmacy. She had placed a clip on her nose to see if it would stop, but when asked to check she said it still has not stopped. Asked her what medications she was taking and if she was on blood thinners. she indicated no. Looked up adverse events on Moderna covid-19 vaccine and it didn't indicate nose bleeding, package insert states "intentionally blank". Advised patient to head to the ER and I would call to check up on her.
tested + for COVID-19 on 05/15/2021, Asymptomatic