chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pt recvd vax;PC from mom;pt had T 101;was pale & listless;seen at er;ped motrin given;mom said "pt perked up,looked & acted nl;mom said V & D started 24 hrs p/ vax;pt followed by PMD;
Timeline: 3/17-3/19 ? ear pressure like in an airplane or driving up the mountain ? Muffled and couldn?t hear much 3/20 ? ear pain inside and behind ? Had little tiny bump behind ear ? Got headache because of ear pain 3/21 6 am ? ear pain ? Bump got bigger ? Headache from the pain ? Pressure in the jaw like I was clenching it because of the ear pain ? R Eye brow twitching ? R Eye lid twitching ? R lip twitching 2 pm  ? Whole Tongue tingling ? R Lip tingling ? R cheek tingling ? R chin tingling 4 pm ? R eye bugging me like I got something in it.  ? Water tasted off: bitter or salty or something ? Tingling in the mouth and tongue stropped ? Ear was bugging me: called dr for ear ache appointment and twitching face (app is Friday 3/25) 7pm ? water tasted metallic  ? Spaghetti nothing ? Ice cream bite nothing ? Brownie bite nothing ? ?Maybe I need sleep? 10 pm ? headed to bed ? But got up for baby till 12:30am 3/23 ? bed at 12:30 am had ear pain inside and behind ? Up 2,3:30,4:45 am for baby ? 3/3:30 am baby slept next to face so I just that my face was numb because of that  ? Bed till 6:30, got up to shower to see if t he pain in my ear would go awake and just wake myself up because I felt OFF. while in shower I tried washing face and I couldn?t move it and feel it on the right side. Tried opening mouth and it felt weird.  ? Husband found me curled up on the shower floor as I told him we needed to go in to the hospital  This all started ? pressure in the ear ? Pain in the ear ? Pressure in the jaw ? Tingling in tongue, lip, jaw ? Eye sensitivity  ? Taste weird ? Numbness and droop ? Slight weakness in Right arm ? R eye won?t close   March 23,2022  3/23 - hospital for ~6 hrs: they discharged me with a complicated migraine 3/23 - neurologist advised me to go to hospital 3/23 - waited at hospital for 8 hrs before going in and being admitted. Wasn?t looked at by a neurologist until 11 hrs later: ruled it :   Ramsey Hunt Syndrome Symptoms: ? right side of the face paralyzed ? Can?t shut my right eye ? Numbness/tingling/twitching r face ? Hard to eat or swollen - so eating smoothies ? Ringing LOUDLY in my ears ? Can?t think straight  ? Sensitive to light in the right eye  ? Ear pressure like in an airplane ? ?Shingles? IN MY ear not able to see it on the outside at all ? Ear is ringing ? Bump (quarter size) under skin behind ear ? Swelling on the full right side around ear, jaw, eye and face ? Can?t taste food ? Water taste metallic and gross - feels like a lot of pressure and ringing then like something pops and then a bit better for 10-20 minutes and then all over again
Mass in right shoulder; deltoid mass; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 04Oct2022 at 14:00 as dose 4 (booster), single (Lot number: GH9702) at the age of 70 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Penicillin" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Naproxen, reaction(s): "Allergy: Naproxen". Vaccination history included: bnt162b2 (other vaccine same date details:, [{other vaccine same date product=Pfizer,, Other vaccine same date lot number=FM0173,, Other vaccine same date vaccine date=04Oct2022,, Other vaccine same date dose number=3,, Other vaccine same date vaccine location=Right, arm}]), administration date: 04Oct2022, when the patient was 70-year-old, for COVID-19 Immunization; Covid-19 vaccine (DOSE 1, SINGLE), for COVID-19 Immunization; Covid-19 vaccine (DOSE 2, SINGLE), for COVID-19 Immunization. The following information was reported: LIMB MASS (non-serious) with onset 06Apr2023 at 12:00, outcome "recovering", described as "Mass in right shoulder"; MUSCLE MASS (non-serious) with onset 06Apr2023 at 12:00, outcome "recovering", described as "deltoid mass". The events "mass in right shoulder" and "deltoid mass" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of limb mass, muscle mass.
COVID Breakthrough  Moderna Dose 1 3/3/21 (029A21A) Moderna Dose 2 3/31/21 (003B21A) COVID Positive 8/28/21  8/28/21: Client is a 72 year old male who presented to ED via EMS with a chief complaint of shortness of breath. He has a past medical history of CAD s/p CABG x3, pacemaker placement, OSA on CPAP, hypertension, hyperlipidemia, rheumatoid arthritis, history of PE, CKD stage G3b and atrial fibrillation anticoagulated on Eliquis. Wilbert started having fevers, body aches, chills and a cough a week ago. He tested positive for Covid-19 5 days, along with his wife.  He finished a course of Azithromycin and dexamethasone. He report diarrhea since finishing his abx, 1-2 episodes per day.  He also takes hydroxychloroquine and sulfasalazine for his rheumatoid arthritis. He has been fully Covid-19 vaccinated. He developed shortness of breath two day ago, worse on exertion. Shortness of breath worsened today and his pulse ox was 83% at home when he called EMS. He denies associated chest pain. He  is anticoagulated on Eliquis and has been compliant.  Last dose taken this morning.  On arrival to ED patient was requiring OxyMask on 8 L. Dexamethasone 6 mg IV given in ED. Laboratory findings were significant for mild hypokalemia 3.4.  CKD stage G 3B BUN 33 and creatinine 1.83.  Leukocytosis 12.03.  Anemia HGB 12 3. D-dimer 0.60.  Chest x-ray showed low lung volumes, no acute process.  EKG atrial paced rhythm, rate 74, QTC 586.  9/1/21: Acute hypoxemic respiratory distress secondary to COVID-19 infection  - possibly related to COVID-19 infection a lower likelihood for embolus.  Was started on remdesivir, dexamethasone p.r.n. DuoNeb treatments, Rocephin/doxycycline, barcitinib.  Initially heparin and then switched to home Eliquis.    Supplemental oxygen as high as 8 L this was gradually weaned down patient was eventually brought to room air. Head O2 walk and did not require any supplemental oxygen. Inflammatory markers were also obtain and trended Trended down.  Patient will be discharged on COVID safe for home program, dexamethasone and barcitinib were discontinued. P.r.n. albuterol inhaler was prescribed on dispo.  Covid-19 Infection  - positive, initial positive on Sunday prior to admission. Received antibody Thursday prior to admission.  Patient reportedly has been vaccinated by moderna 2/2. Acute management as noted above.  Room air clinically well prior to discharge will follow-up with PCP as discussed
I got a sinus headache; body ached; Terrible feeling; lost all energy; was cold; This is a spontaneous report from a contactable consumer(patient). A 61-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN9581) via an unspecified route of administration, administered in right arm on 18Feb2021 12:00 as single dose for COVID-19 immunization. Patient medical history included Early Onset Alzheimers, high blood pressure, acid reflux, diverticulitis, and allergies to pollen and ragweed. Past drug event included Lipitor orifarm, amlodipine for allergies (Hypersensitivity). The patient concomitant medications were not reported. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL3247) via intramuscular, administered in arm Left on 28Jan2021 12:00 as single dose for COVID-19 immunization. Patient stated that on 19Feb2021 01:00 when she was in store, she had terrible feeling came over her. She lost all her energy, she got a sinus headache, she was cold, her body ached all over. She had to leave the store. Barely had enough energy to walk from the car into her house. The patient did not receive any other vaccines prior to the COVID vaccine in four weeks. Patient received other medications in two weeks after vaccination. Patient did not receive any treatment for AE. Patient was not tested covid prior vaccination or post vaccination. The clinical outcome of events was not recovered.
Swelling in arm and in lymph nodes across neck area on right side of torso, soreness under arm area on day one. Day two fever 101.5 x 12 hours followed by bright red area on arm at shot sight 3"x3", day three fever 99.5 and arm redness spreading to inside of arm near armpit, extremely sensitive to touch. Headache and sleepy most of two days.
This spontaneous case was reported by another health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adult mistakenly), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patient post temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Moderna COVID-19 vaccine administered to patient post temperature excursion) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR5186C) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adult mistakenly), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patient post temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Moderna COVID-19 vaccine administered to patient post temperature excursion) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adult mistakenly), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patient post temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Moderna COVID-19 vaccine administered to patient post temperature excursion) and NO ADVERSE EVENT (No adverse event) outcome was unknown.         Concomitant product use was not provided by the reporter.    This case contains information for the 88 of 104 patients described by the reporter.
11/15 throat was closing. Entire body covered with a violent red rash. 11/15 went to er x 2 and Dr. office x 7 hours. 11/16 back to Dr office. Later: found out pt ate coconut macroons with nuts. 15 minutes after symptoms started
Had all the general side effects listed for the last 2-3 days; Stiffness throughout body; Weakness in the entire arm on injection side.; low grade fever; Chills; Nausea; Fatigue; Headache; General muscle pain; Joint pain; Pain at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Had all the general side effects listed for the last 2-3 days), MUSCULOSKELETAL STIFFNESS (Stiffness throughout body), MUSCULAR WEAKNESS (Weakness in the entire arm on injection side.), PYREXIA (low grade fever) and CHILLS (Chills) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049C21CA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 16-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Jul-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (Stiffness throughout body), MUSCULAR WEAKNESS (Weakness in the entire arm on injection side.), PYREXIA (low grade fever), CHILLS (Chills), NAUSEA (Nausea), FATIGUE (Fatigue), HEADACHE (Headache), MYALGIA (General muscle pain), ARTHRALGIA (Joint pain) and VACCINATION SITE PAIN (Pain at the injection site). On an unknown date, the patient experienced VACCINATION COMPLICATION (Had all the general side effects listed for the last 2-3 days). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency and ACETAMINOPHEN for Adverse event, at an unspecified dose and frequency. On 22-Jul-2021, MUSCULOSKELETAL STIFFNESS (Stiffness throughout body), MUSCULAR WEAKNESS (Weakness in the entire arm on injection side.), PYREXIA (low grade fever), CHILLS (Chills), NAUSEA (Nausea), FATIGUE (Fatigue), HEADACHE (Headache), MYALGIA (General muscle pain), ARTHRALGIA (Joint pain) and VACCINATION SITE PAIN (Pain at the injection site) had resolved. At the time of the report, VACCINATION COMPLICATION (Had all the general side effects listed for the last 2-3 days) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were reported.   Most recent FOLLOW-UP information incorporated above includes: On 13-Aug-2021: Significant follow up added on 13-Aug-2021, patient details height, weight and race, added batch number anatomical location, added events.
REPORTED:  ARM SORENESS, BRUISING, LETHARGY FOR 1 WEEK, RADIAL TENDONITIS INJURY REAGGRAVATED, EFFECTS BEGAN WITHIN A FEW HOURS AND LASTED 1 WEEK
A non-serious spontaneous report of gave H1N1 to a man over 50 year old was received from a registered nurse concerning a 60-year-old male. Neither relevant medical history nor concomitant medications have been reported for this patient. On 17-Nov-2009 patient received H1N1, Intranasal, for an unknown indication. There was no adverse event associated with this medication error therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved.
Right after receiving the Moderna vaccine as I was waiting the 15 minutes I began to experience a burning sensation on my back on the left side. I continued to wait the 15 minutes before leaving the Vaccination site. I went home and I was experiencing some itching to my back. I checked my back but saw nothing there. It was the next day on April 14, 2021 that I noticed a rash on my back on the left side. I thought it was a spider bite and figured it would get better but it did not and so I made an appointment with my primary care doctor and I saw him on April 20, 2021 and that is when I was told me that it was not a spider bite but in fact it was Shingles. I explained to my doctor what had occurred and what lead up to me scheduling the appointment.
Significant vertigo, ringing in left ear (bad ear) and siren sound in right ear which is my good ear
Narrative: Nurse vaccinated patient with covid-19 booster in right deltoid today. when needle removed from arm post vaccination, gentle pressure held approx 5 seconds. When nurse removed pressure, site started to bleed a moderate amount. Nurse applied bandaid, gauze and pressure x approx. 30 seconds. Bleeding stopped. Nurse was unable to see if any of the vaccine leaked due to blood.
Energy decreased/ Energy level does limit daily activities; Energy level does limit daily activities/ Activities of daily living impaired; Not feeling well/ Feeling Unwell/Does not feel better after resting; Fatigue/ symptoms of fatigue; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Energy decreased/ Energy level does limit daily activities), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Energy level does limit daily activities/ Activities of daily living impaired), MALAISE (Not feeling well/ Feeling Unwell/Does not feel better after resting) and FATIGUE (Fatigue/ symptoms of fatigue) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ENZALUTAMIDE (XTANDI) for Prostate cancer.    No Medical History information was reported.   In July 2021, the patient started ENZALUTAMIDE (XTANDI) (Oral) 160 milligram once a day. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ASTHENIA (Energy decreased/ Energy level does limit daily activities), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Energy level does limit daily activities/ Activities of daily living impaired), MALAISE (Not feeling well/ Feeling Unwell/Does not feel better after resting) and FATIGUE (Fatigue/ symptoms of fatigue). At the time of the report, ASTHENIA (Energy decreased/ Energy level does limit daily activities), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Energy level does limit daily activities/ Activities of daily living impaired), MALAISE (Not feeling well/ Feeling Unwell/Does not feel better after resting) and FATIGUE (Fatigue/ symptoms of fatigue) outcome was unknown.            No concomitant medications were reported.  It was reported that patient had level 2 out of 10 fatigue. Patient had no symptoms of hand-foot syndrome. Patient again reported moderate fatigue and selected 6 out of 10 for fatigue level. MD told the patient to hold off on Enzalutamide for a week and then call to Follow Up and decide on dose restart (around 21-Dec-2021). The patient was prescribed with 1 tablet of enzalutamide daily.  No specific treatment medications were reported.
She develops a little smaller on that her left arm with some pimples and a rash towards her back towards her the left arm/painful also itchy; She develops a little smaller on that her left arm with some pimples and a rash towards her back towards her the left arm/painful also itchy; developed a rash on her vagina; vagina is all red, itchy and also a little pain in her vagina; developed a rash on her vagina; vagina is all red, itchy and also a little pain in her vagina; developed a rash on her vagina; vagina is all red, itchy and also a little pain in her vagina; This is a spontaneous report received from a contactable consumer (Patient husband). A 67-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 intramuscular on an unspecified date (Lot Number: ER8727) as SINGLE DOSE for covid-19 immunisation.  Medical history included diabetic and high blood pressure. The patient's concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 (lot number: EN6206) as single dose for covid-19 immunisation. On her first shot that she had she developed small round rashes in the back like a four pimple that appear on 19Mar2021, and with the second vaccine, two days later she developed a little smaller on that her left arm with some pimples and a rash towards her back towards on the left arm and she visited her dermatologist today (15Apr2021) and she have been prescribed with some cream(Treatment) to alleviate the pain, the itching they actually they were painful also itchy and also she developed a rash on her vagina. When paraphrased the concern, reporter stated,  "Yes, it also in her vagina is all red, itchy and also a little pain in her vagina." The date 09Apr2021 that was when the second rash appeared. The first rash appeared on 19Mar2021. The outcome of the events was not recovered. No follow-up attempts are needed. No further information is expected.
Pt's mom called, notified us of golf ball size red raised area left deltoid where DPT & IPV were given.
had to go to the emergency room  was feeling so rotten.; Initial information was received on 03-Oct-2021 regarding an unsolicited valid Social Media non-serious case (under reference number: US-SA-SAC20211006000095).  This case involves adult patient with an unknown gender who experienced non serious event "had to go to the emergency room was feeling so rotten" (malaise) while receiving INFLUENZA VACCINE.  The patient's medical history, past medical treatments, concomitant medications, vaccinations and family history were not provided.   It was unknown if the patient had any concomitant disease or risk factor.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number and expiry date not reported via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious event "had to go to the emergency room was feeling so rotten" (malaise) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "the patient got a so called senior shot after being pumped by the doctor after not having a flu for many years. Almost had to go to the emergency room was feeling so rotten. Nope, no more."  It was unknown if the patient experienced any additional symptoms/events.  There were no lab data/results available.  It was not reported if the patient received a corrective treatment for the event.  On an unknown date, at time of reporting, the outcome of event was reported as unknown.  There will be no information on lot number for this case.
PT RECEIVED A PEDIATRIC PFIZER DOSE, BUT DUE TO AGE, HE SHOULD HAVE RECEIVED AN ADULT DOSE FOR 12 AND OLDER.
Patient received shot on Friday with no issue. Patient stated Saturday that they observed no nausea but fever, chills, and general malaise that would spike several times a day. Patient said he felt terrible and when he woke up, he felt a knot the size of a tennis ball under left arm. Patient went to an ER and providers stated that it appeared to be a lymph node reaction with no further additional treatments to therapy. Patient called the pharmacy on Tuesday to say it was getting much better but knot, will smaller (approximately the size of a golf ball), is still present.
Major Complex Seizure with post-ictal period of 2 hours, occurring 3 hours after receiving injection.   16 days later on March 6, 2021  was unable to void, sustained breathing difficulty with peripheral edema. Received diuretic from Nurse,. Indwelling Catheter was inserted.  On day 17, after receiving  Corvid Vaccine, DECEASED on March 7, 2021 at home. Sustained Complex Seizure 6 hours prior.  Death Certificate ruling Cause of Death as Cardiac Arrhythmias.
High fever, lasting five days, reaching as high as 106; Also, after second administration, same symptoms (high fever) though occurred sooner, and fever only as high as 104
COVID breakthrough vaccine. Fully vaccinated, tested positive for COVID > 14 days after completing vaccine series.  Known COVID exposure, mild symptoms.
Pt with recurrent ear and upper respiratory infections received vax on 06/25/1997. Shortly after vax the pt experienced diarrhea and a fever of 103-104F for 4 days. Subsequently she developed a roseola rash. On 08/06/1999 the pts mother developed shingles and on 08/12/1999 the pt developed a breakthrough rash of chickenpox of approximately 10 flea bite lesions described as erythematous non-umbilicated vesicular eruption located on the pts trunk bilaterally. The lesions were not itchy. She also experienced two weeks of cold symptoms. Due to symptoms the pt was presented to a physician.
He received IV SOLUMEDROL followed by short course of prednisone for rash following administration of his influenza vaccine. Patient reports he is feeling well. Rash resolved in 3-4 days. Erythematous rash to the entire extremity.  Methylprednisolone 125 mg once, diphenhydramine 25 mg once.
Pt received 1st COVID-19 vaccine on 3/2/2021 (Pfizer).  He was admitted to his local hospital earlier in the week with worsening respiratory status, progressed to needing intubation and was transferred to our hospital for a higher level of ICU care.  On 3/23/2020 he tested positive for COVID-19 via SARS-CoV-2 PCR NP swab.  He is still currently inpatient.
Patient just found out that she is pregnant and they suspect she is 7 weeks pregnant - she would have been 5 weeks pregnant at the time
Metallic taste in mouth, odd sensation in lower lip,. Lasted about 4 hours.  Chills, fever, body and joints aching, headache, nausea,  sore arm. Lasted about 36 hours