chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Her right eye had puffed and swollen shut.; Her right eye had puffed and swollen shut.; This spontaneous case was reported by a consumer and describes the occurrence of EYE SWELLING (Her right eye had puffed and swollen shut.) and PERIORBITAL SWELLING (Her right eye had puffed and swollen shut.) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included ESCITALOPRAM for an unknown indication.    On 12-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Nov-2021, the patient experienced EYE SWELLING (Her right eye had puffed and swollen shut.) and PERIORBITAL SWELLING (Her right eye had puffed and swollen shut.). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date for Adverse event, at an unspecified dose and frequency. At the time of the report, EYE SWELLING (Her right eye had puffed and swollen shut.) and PERIORBITAL SWELLING (Her right eye had puffed and swollen shut.) outcome was unknown.
DIZZY ALL DAY 10-08-2004. TOOK QTY. 1 MECLIZINE TAB. OK NEXT DAY!
Tested negative for Covid on May 26, 2022. Started to have Covid symptoms and tested positive again on May 31, 2022. This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Tested negative for Covid on May 26, 2022. Started to have Covid symptoms and tested positive again on May 31, 2022.) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Patient had no known allergy.  Concurrent medical conditions included Blood pressure high.    On 06-Apr-2022 at 4:00 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-May-2022, the patient experienced COVID-19 (Tested negative for Covid on May 26, 2022. Started to have Covid symptoms and tested positive again on May 31, 2022.). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 21-May-2022 to 25-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (Tested negative for Covid on May 26, 2022. Started to have Covid symptoms and tested positive again on May 31, 2022.) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-May-2022, SARS-CoV-2 test: negative (Negative) Negative. On 31-May-2022, SARS-CoV-2 test: positive (Positive) Positive.         No concomitant medication were reported. The Device Date :02-Jun-2022.  Company Comment: This spontaneous case reported by a patient concerns a 63-year-old male patient, with no relevant medical history, who experienced unexpected, non-serious Covid19, around 1 month and 3 weeks after receiving a third dose of mRNA-1273.  He was treated with a 5-day course of Nirmatrelvir/Ritonariv (Paxlovid) and tested negative for Covid19 the next day.  However, around 3 days later he started to have Covid19 symptoms and tested positive for Covid19 again.  The ongoing Covid19 pandemic could be a contributory factor.  The benefit risk relationship of mRNA-1273 is not affected by this report. Sender's Comments: This spontaneous case reported by a patient concerns a 63-year-old male patient, with no relevant medical history, who experienced unexpected, non-serious Covid19, around 1 month and 3 weeks after receiving a third dose of mRNA-1273.  He was treated with a 5-day course of Nirmatrelvir/Ritonariv (Paxlovid) and tested negative for Covid19 the next day.  However, around 3 days later he started to have Covid19 symptoms and tested positive for Covid19 again.  The ongoing Covid19 pandemic could be a contributory factor.  The benefit risk relationship of mRNA-1273 is not affected by this report.
High fever recorded 102 degrees - 103 degrees, chills, severe headache, muscle pain, joint pain even acet.
Severe lower back pain; I couldn't walk; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Severe lower back pain) and GAIT INABILITY (I couldn't walk) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced BACK PAIN (Severe lower back pain) and GAIT INABILITY (I couldn't walk). The patient was treated with NAPROXEN at an unspecified dose and frequency. At the time of the report, BACK PAIN (Severe lower back pain) and GAIT INABILITY (I couldn't walk) had not resolved. Not Provided      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.   No relevant concomitant medications were reported.
Stopped breathing & turned blue. I know it was Hep B but I don't know Lot # or any other information.
Patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021; Patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Apr-2021 at 10:47 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 29-Apr-2021 at 10:47 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 26.22   Concomitant products were not provided.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F.  Temperature recordings were taken using a Fisherbrand traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  On 29-Apr-2021 excursion time was reported at 10:00 A.M with  temperature as 33 degrees Fahrenheit, total doses given for the day was 201, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 19-Apr-2021, vial was moved to clinic on 29-Apr-2021, 5 vials were sent to clinic. Vaccine BUD date was 19-May-2021.  On 29-Apr-2021, vials were stored on cooler 1, at following time and temperature respectively at 9 AM: 36, 10 AM: 33, 11 AM: 44, 12 APM: 45, 1PM: 45, 2 PM : 44, 3 PM: 45, and 4 PM: 44   The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Treatment medications were not reported.
Patient was vaccinated and some minutes later said he was unable to breath, that his tongue was swelling and then stopped responding to his name. Clinic staff attended to the patient, administered Epi (1 epi jr, 1 epi adult), called EMS and a physician at Health Center. EMS arrived around 10:25am and at this time patient was responsive and talking. Patient was transferred to a nearby hospital by EMS for further evaluation.
Reported tinnitus after second Moderna vaccine. Worsened with intermittent loss of hearing after booster dose. Referred to ENT for evaluation 12/21/2021.
Left side facial numbness starting with the left tip of tongue spreading to left side of lips, then left cheek, then left forehead.  Continues to intensify and spread.  Now surrounds left eye; extremely concerned as I am blind in my right eye.; This is a spontaneous report from a contactable consumer. This 74-year-old male consumer reported for himself received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) via an unspecified route of administration, administered in Arm Right on 02Feb2021 09:00 (Batch/Lot Number: EN5318) as 2ND DOSE, SINGLE DOSE, and via an unspecified route of administration, administered in Arm Right on 12Jan2021 09:00 (Batch/Lot Number: EL1283) as 1ST DOSE, SINGLE  DOSE for covid-19 immunisation.  Medical history was none. Concomitant medication(s) included latanoprost taken for an unspecified indication, start and stop date were not reported; donepezil hydrochloride (ARICEPT) taken for an unspecified indication, start and stop date were not reported.  The patient stated of experiencing "left side facial numbness starting with the left tip of tongue spreading to left side of lips, then left cheek, then left forehead. It continues to intensify and spread and now surrounds left eye" and stated that he "extremely concerned as I am blind in my right eye). Onset date for events was 1Feb2021. Events reported as medically significant . Outcome of events was not recovered.  Patient had ongoing consult neurologist and was scheduled for MRI. Patient did not have covid or tested positive prior to vaccination.
Pt received pneumovax in right deltoid, by next day arm was sore, swollen and red.  Pt instructed to ice site and take Tylenol/Motrin, site worsened and pt bought into office 2/23/07 2:20 for an appt with dr.
Same flu-like symptoms that patient had previously, lasted for a day, less severe this time around.
Sent to ER on 3/25/21 for stroke-like symptoms. Found to have had a stroke with test results
8 hours after the vaccine felt fatigue, had 103 fever, body chills and aches, sweats, head pressure. Took Tylenol and fever went down. Woke up Sunday with 101 fever, aches, took Tylenol again and sweat it out. Fever went away completely but had nausea and diarrhea. That lasted 2 days. Tuesday morning started feeling congested, sinus pressure ringing in ears when laying down, Thursday noticed mild smell and taste. Tested positive for Covid via a rapid test. Friend who had vaccine same day same exact symptoms also tested positive, were never near each other and no one else around me is sick.
Patient contracted COVID after being fully vaccinated cough, Congestion, Runny nose, fatigue, fever
she feels like there's a fluid on her ear; dizziness; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of EAR DISCOMFORT (she feels like there's a fluid on her ear), DIZZINESS (dizziness) and FATIGUE (fatigue) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included NAPROXEN (MIRAMAX) for Constipation, MULTI VITAMIN & MINERAL for Supplementation therapy.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced EAR DISCOMFORT (she feels like there's a fluid on her ear), DIZZINESS (dizziness) and FATIGUE (fatigue). At the time of the report, EAR DISCOMFORT (she feels like there's a fluid on her ear), DIZZINESS (dizziness) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Rash developed on left arm that had the vaccine the next day.  Had little bumps on it, and was itchy.   Rash spread from left arm, up to shoulder, and across neck to other arm.   Lasted 6 days
Patient presented day after injected at pediatricians office. Head to toe rash with swelling in eyes and fever of 100.2 temporal.
24 hours after injection was given she developed hives primarily on thigh and buttocks.  Her skin was diffusely erythematous from buttocks to feet, puffy but it spread to knees and thighs though no induration or warmth to skin. Ik was able to arm flat and had joint exam. There were a few urticaria.  No respiration symptoms.
Pt found out she was pregnant after receiving the MMR and TD vaccine on 3/29/01. She was counseled at time of visit to avoid pregnancy for 3 months.
Severe headache and dizziness resulting in hospitalization for Lupus and RA flares
Pfizer-BioNTech COVID-19 Vaccine EUA:  patient presented to  emergency department with chest pain. Diagnosed with NSTEMI with severe coronary artery disease. Underwent CABG without complications and discharged to home medically stable.
got "pretty sick" (after 2nd dose); swollen lymph nodes (after 2nd dose); This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (got "pretty sick" (after 2nd dose)) and LYMPHADENOPATHY (swollen lymph nodes (after 2nd dose)) in a 35-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, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ILLNESS (got "pretty sick" (after 2nd dose)) and LYMPHADENOPATHY (swollen lymph nodes (after 2nd dose)). At the time of the report, ILLNESS (got "pretty sick" (after 2nd dose)) and LYMPHADENOPATHY (swollen lymph nodes (after 2nd dose)) outcome was unknown.            No Concomitant medication was reported.     No treatment medications were reported.   This case was linked to MOD-2021-404744, MOD-2021-404759 (Patient Link).
Vaccine given 11/10/06.  Within 12 hours, pt. was in severe pain at the site of the injection (upper rt. arm).  The pain was intense, at a 9/10 level on a 10-pt. scale.  The pain would decrease to a 5/6 level off and on.  This continued for 3 weeks, with no relief from prescriptions for Vicodin nor Ultram. Please note:  I do not know the name of the flu vaccine I received, so the "guess" in box 13 may well be incorrect. As the weeks continued, the pain progressed from the upper rt. arm to the rt. shoulder, across the back, up the neck, and into the left shoulder.  Pain continued varying from 5/6 to 9/10 with no discernable pattern or causation. Now in the fifth week, the pain has diminished to a consistent level 4/5.  I (the pt.) am taking up to 1800 mg. Ibuprofen daily. There never was any outward sign of trauma, no redness, swelling, hives, etc.  An MRI (rt. arm) produced 3 1/2 wks. after the injection was negative. Neither my family physician nor my neurologist could determine any cause other than the apparent vaccine.
On day 8 after my shot my arm starting felling warm and the skin felt tight.  On day 9 I had a raised red circle that was warm to the touch and itchy. On day 10 it starting spreading and was lighter red, more mottled looking.  It took a few more days for the shading to disappear.
Arm soreness; Headache; Dizziness; This case was reported by a nurse and described the occurrence of pain in arm in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site discomfort (received 1st dose on 28th August 2019, refer case US2019AMR199256).   On 28th October 2019, the patient received the 2nd dose of Shingrix. In October 2019, less than a week after receiving Shingrix, the patient experienced pain in arm, headache and dizziness. On an unknown date, the outcome of the pain in arm, headache and dizziness were recovering/resolving.   It was unknown if the reporter considered the pain in arm, headache and dizziness to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and had arm soreness, headache and dizziness. No additional information was provided. The reporter consent to follow up. This case linked with US2019AMR199264 and US2019AMR199268, reported by same reporter.
Shortly after I got home, within  the hour; My husband told me  when I got home I started acting  loopy.   by 5pm - it was if I was drunk, halucinating and talking jibberish.    By 6pm  I passed out but restless - no fever but knocked me out for over 10.5 hours (I normally sleep 6 hrs a night).   Woke up the next morning with no other reaction but a sore arm.
PT DESCRIBED PRURITIC RASH OVER CHEST, LEGS ~1.5 TO 2 HOURS FOLLOWING VACCINATION
Periods of tachycardia with puke going up to 189 and lasting for 10-15 minutes at a time   Hypertensive crisis - blood pressures from 180/133 and for 8 days since 2nd shot BP has been vhigh averaging 135/108 with metoprolol and propranolol on board.
At 12 noon vaccine administered on 2/26/14, that early evening pt c/o sore arm and (R) thigh to behind knee to hip severe pain. Didn't receive any medical care as she didn't report these complaints till 3/25/14. Denied fever, rash, area was sensitive to touch.
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age. On an unknown dates the patients were vaccinated with a doses of improperly stored M-M-R II (dose, route of administration, lot number were not reported). There was no adverse effects reported. Product Quality Complaint (PQC) was not involved. Additional information has been requested.
took immunization about 11:30am 10/28/2005 when took nap that afternoon had bizarre dreams, that evening began to swell get red and hot, through next day continued swelling maximum size tennis ball was hot, hard, tender, did not ever take temp, talked with someone on 10/31/2005 3 days after injection. Site has went from size to tennis ball to current size of egg, cont red, hard tender and itching, is still having crazy dreams. 01/01/2005 talked to someone again, no itching today, did not have strange dreams 2st time last night and swelling almost gone, historically had a reaction like this 1x with TD immunization, but took Hep A x2 with no problems at all.
Really sore arm, neck, shoulders & back, headache  and fever for 2 days so far. Taking tylenol & advil.
Pt returned to vacc. clinic with HA and dizziness. Stated afraid will fall over in the patient room.  B/P 92/87, 110/68.  O2 sats WNL.  Discussed Benadryl and Pt refused. observed Pt for 15-20 min and sent to ED since dizziness had not improved and c/o was concerned about falling. "feels Like I'm going up and down in an elevator."
Body aches, headaches, treated with Aleve ; extreme fatigue- treated with sleep. Felt like I had a fever but I didn?t register over 99
Redness, swelling distal to site. Isolated blister adjacent to the area. Pain/swelling mainly. Tx'ed with ibuprofen and cool compresses with improvement.
He presented with acute onset chest pain and was found to have elevated troponin I and BNP. He had received his first COVID vaccine on 12/13/21 and his second dose on 2/24/22. Symptoms started 2/27/22.  His chest pain resolved shortly after admission.  He received 2 doses of IVIg and is on day 6 of steroids. Troponins continue to down trend after 2nd dose of IVIg but remain elevated. he remains hospitalized
swelling in lt cheek & neck glands-fever 100.5; tx Cephalexin-APAP;
Daughter had minimal common side effects after the second dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Daughter had minimal common side effects after the second dose) in a 22-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Daughter had minimal common side effects after the second dose). At the time of the report, VACCINATION COMPLICATION (Daughter had minimal common side effects after the second dose) outcome was unknown.            No concomitant medications were provided.  No treatment medications were reported.   This case was linked to MOD-2022-546533, MOD-2022-546543 (Patient Link).   Reporter did not allow further contact
Hospitalized with COVID; Hospitalized with COVID; Hospitalized with pneumonia; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): US-ABBVIE-4715018, US-ABBVIE-4714204.  A 55-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (prolonged hospitalization, medically significant), SUSPECTED COVID-19 (prolonged hospitalization, medically significant) all with onset 2022, outcome "unknown" and all described as "Hospitalized with COVID"; PNEUMONIA (prolonged hospitalization, medically significant) with onset 2022, outcome "unknown", described as "Hospitalized with pneumonia".  Clinical course: In 2022, patient was hospitalized with Covid and hospitalized with pneumonia a second time. He stated that he took the Pfizer Covid vaccine and had been sick ever since getting the covid vaccines.  The reporter's causality for the event(s) of COVID and pneumonia with Pfizer BioNTech COVID-19 vaccine (Tozinameran) was Not Provided. Agency's opinion was that the causality for the event(s) of COVID and pneumonia with Pfizer BioNTech COVID-19 vaccine (Tozinameran) was Not Provided.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300064269 Same patient, different drug and event;US-PFIZER INC-PV202300064749 Same patient, different drug and event;
Hair falling out, diagnosed with ulcerative colitis, lichens sclerosis, unexplained R sided facial numbness with intermittent tingling, a pituitary tumor, adrenal insufficiency, chronic fatigue, nausea, light headedness, worsening vision and severe insomnia that have all been diagnosed within the last 5 months. The ulcerative Colitis symptoms have been since March of 2021. Physicians cannot find out why I am suddenly finding autoimmune disease and losing my hair at age 29. MRI showed no damage to my R side trigeminal nerve to be causing this numbness for the last 5 months. I am being treated with Cabergoline for the pituitary tumor, diet control with turmeric for UC control for now, Clobetasol 0.05% ointment for lichens sclerosis, minoxidil for hair loss, hydroxyzine for insomnia and further testing is being completed prior to being treated for adrenal insufficiency.