chrisvoncsefalvay/vaers-outcomes huggingface dataset:
My symptoms began on 5/13 and were mainly just a runny nose and it got fairly severe, but we were on a vacation and I suffer from allergies so I assumed I was just experiencing some allergy issues. But as it got worse and worse, I decided to rest for a few days while on vacation. Since returning home, I'm still having a runny nose accompanied by an excess of phlegm. I'm constantly blowing my nose and have been taking Benadryl to treat the symptoms which helps. I spoke with a physician's assistant over the phone when I returned from vaction on 5/20 after taking an at home Covid test which came back positive. She advised that I just isolate and monitor and treat my symptoms with over the counter medication as it was too late for me to be prescribed an antiviral. I've been feeling pretty good for a few days but today my runny nose and cough have gotten a bit worse and the Benadryl does not seem to be as effective as it was before.
Information has been received from a medical assistant on 15JUN2015 concerning a patient (age and gender not specified). The medical assistant reported that on 10JUN2015 the patient was vaccinated with a dose of improperly stored LIQUID PEDVAXHIB. No adverse effects were reported. This is one of several reports from the same source. Additional information is not expected.
Pt left arm warm to touch, hard around and near injection site, pt states she talked to doctor prior nothing was done at doctors office.
Developed urticaria, 2 days after receiving vaccines. It included his face, trunk and extremities.
Nausea; Headache; Lethargic; Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (Lethargic), DIARRHOEA (Diarrhea), NAUSEA (Nausea) and HEADACHE (Headache) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced LETHARGY (Lethargic), DIARRHOEA (Diarrhea) and HEADACHE (Headache). On 24-Mar-2021, the patient experienced NAUSEA (Nausea). The patient was treated with CARISOPRODOL (SOMA [CARISOPRODOL]) ongoing since an unknown date at an unspecified dose and frequency and MORPHINE ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, LETHARGY (Lethargic), DIARRHOEA (Diarrhea), NAUSEA (Nausea) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product information was not provided.   This case was linked to MOD-2021-259305, MOD-2021-259305 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 18-Jul-2021: Treatment Medications updated.
After influenza vaccine, patient was able to cut wood for a few hours.  Later in the day, went to meet friends and began to feel "as stiff as a board", had headache, felt weak and his legs ached at approximately 6:30pm, came home and temp was 101. Took some ibuprofen, slept in recliner over night.  This morning, fever and headache were gone and the weakness improved but legs remain a little sore and achy. Patient did not phone medical provider.  Writer updated MD today.
GUILLAIN BARRE SYNDROME; BRAIN DAMAGE; HEART DAMAGE; This spontaneous report received from a consumer concerned a 48 year old female of unspecified race and ethnic origin The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose was not reported,1 total, administered on an unspecified date in APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On unspecified date in JUN-2021, the patient was hospitalized (number of days hospitalized was unspecified) and diagnosed with Guillain barre syndrome, the magnetic resonance imaging indicated brain and heart damage (date unspecified), she could not stand, inability to walk, had limited feeling below knees and no feeling in her fingertips. She was in rehab until last week and had regained ability to walk in rehab. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the heart damage, brain damage and guillain barre syndrome was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210915626-covid-19 vaccine ad26.cov2.s- brain damage, heart damage. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).  20210915626-covid-19 vaccine ad26.cov2.s-Guillain Barre syndrome. This event(s) is labeled per RA and is therefore considered potentially related.
Abnormal menstrual cycles, more than normal in a regular cycle period.  Bleeding 14 days out of 21. Brain is fuzzy.  Hair is falling out. Headaches. All these things started to happen after the first dose.
Reporter states that approx 1/3 of the employees treated to date w/Engerix-B failed to respond or had borderline titer levels produced (over the past 15 months) p/3rd dose; sixty to seventy employees have been treated to date;
DARK ORANGE URINE; BOTH EYES HURTING; NAUSEA; TIREDNESS; This spontaneous report received from a patient concerned a 22 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included social alcohol drinker, and non-smoker, and other pre-existing medical conditions included the patient had no known allergies. the patient had no history of drug abuse or illicit drug use. the patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, and expiry: 07-AUG-2021) dose was not reported, administered on 11-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-JUL-2021, the subject experienced dark orange urine. On 11-JUL-2021, the subject experienced both eyes hurting. On 11-JUL-2021, the subject experienced nausea. On 11-JUL-2021, the subject experienced tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from dark orange urine, both eyes hurting, nausea, and tiredness. This report was non-serious.
Patient complained of chest tightness  15 mins after receiving vaccine. She noted that she has seasonal allergies, had same symptom and was seen by her PCP and received ABx. She denies any other symptoms. Patient assessed and evaluated by NP and EMT. Blood Preassure - 139/76.
Patient is having a flare up of psoriasis symptoms, including psoriatic arthritis (muscle ache and weakness, fatigue)
Moderna Vaccine was requested for patient by Father.  Patients (older) brother had severe reaction to the Pfizer Vaccination.  Injection of Moderna was given then realized patient was 16.  Discussed fact with Father that Moderna not yet approved for under 18, father denies concerns, reiterated that he asked for Moderna.
COVID positive on 12/17/2022. Began with constant runny nose, two days later lost sense of smell, no fever, mild diarrhea, body aches, general fatigue. Began PaxLovid 12/18/2022. Symptom free and tested negative 12/26/2022. Symptoms returned full-force 12/28/2022. Doctor advised rest and home care with no further PaxLovid as it was likely a rebound of the prior infection.
pt recv vax MAY96 & 8MAY97 pt devel a serious case of chickenpox that consisted of 200 lesions over body including throat & ears;
Patient received her vaccine at 1343. She was seated in the 15 minute waiting area.  She went to the RN observation desk to check out at 1405 when her observation time was up. Nurse educated patient about signs/symptoms to watch out for in the next 48 hours, including tachycardia. Patient then shared that her heart rate had been elevated since her injection. She states she thought it was just nerves/anxiety, but thought that she should mention it now.  Nurse directed her to EMS for evaluation. This RN accompanied patient to EMS where she was placed on a monitor.  Patient stated she was tracking her own pulse via smartwatch, reported it to be in the 130's just after injection. She stated she was able to bring it down to the 80's while sitting.  Per EMS, her pulse was stable in the high 90's.   Patient reports a history of childhood tachycardia, but states she was cleared by her cardiologist 5+ years ago. She takes daily synthroid, prescription zyrtec, pantoprazole, and celexa. She has PRN ativan for anxiety, takes it infrequently. She took all of her scheduled medication this morning.  She has an allergy to erythromycin (GI cramping) and penicillin (hives in childhood).   EMS performed 12 lead EKG at 1421 -- Normal Sinus Rhythm, vital signs 118/78, pulse 89, oxygen 99%.  Second set of vitals at 1430 were 109/78, pulse 86, oxygen 99%.  Patient reports feeling fine, would like to go home if cleared.  EMS agreed.  RN reminded patient to watch for symptoms over the next 48 hours, to call 911 if she has any additional cardiac symptoms, any oral swelling, difficulty breathing or swallowing, hoarseness, chest pain or tightness.  She will follow up with her primary care physician for direction about the booster vaccine. She requested that the notes be sent to her primary care and cardiologist (RN unable to find cardiologist in her record, patient could not recall his name at this time).
Three days post vax, the pt developed severe sharp needle like prick pain in deltoid at the site of injection and deep aching pain in the left shoulder followed by prickling numbness in left arm, forearm and hand.
Tested positive for Covid-19/She had cold symptoms, cough, lots of nasal congestion.; ear infection/ear drainage; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 (Tested positive for Covid-19/She had cold symptoms, cough, lots of nasal congestion.) and EAR INFECTION (ear infection/ear drainage) in a 36-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 055F22B) for COVID-19 prophylaxis.     The patient's past medical history included Atrial septal defect, Subvalvular aortic stenosis, Open heart surgery (Hole in heart) and Open heart surgery (Sub aortic stenosis). Concurrent medical conditions included Down's syndrome.    On 29-Sep-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 02-Oct-2022, the patient experienced COVID-19 (Tested positive for Covid-19/She had cold symptoms, cough, lots of nasal congestion.) and EAR INFECTION (ear infection/ear drainage). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) at an unspecified dose and frequency. At the time of the report, COVID-19 (Tested positive for Covid-19/She had cold symptoms, cough, lots of nasal congestion.) and EAR INFECTION (ear infection/ear drainage) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Oct-2022, SARS-CoV-2 test: (Positive) Positive. No concomitant drug information was provided. Patient had experienced the symptoms of cold, cough and lots of nasal congestion and ear drainage. Treatment medications included medicines for an ear infection.
Fever 99.8 for 24 hours; head ache approx 9 hours; joint pain mostly neck, shoulders, hips continues to persist; muscular weakness which persists as well localized primarily to upper extremities; had sharp pains in mediastinum left side, intermittent for several hours the day after the injection, difficult to tell if the pains were heart or lung related.  These pains were the most scary part.;   General malaise for about 24 hours.
1/15/23  I noticed a smoky smell in my nose. Sometimes it was like you were around a bonfire. Other times it would make me sneeze.  My smell was not altered because I could smell other things. It was time for me to renew my nasal sprays, so I needed to see my ENT. When I saw her, I mentioned the smoky smell I was experiencing.  She did a nasal endoscopy; she noticed a small amount of inflammation and green drainage on the left side.  I was treated with Azithromycin  and nighttime nasal rinses that contained a steroid for 20 days. The smoky smell had improved but had not gone away.  At my follow up appointment after 20 days, 2/21/23, the doctor did a CT of my sinuses. It showed everything had cleared, no infection.  My doctor said there are a few neurological conditions that can cause a smoky smell.  I had an MRI of my brain and there was nothing explanatory for a smell, there was an area of vascular malformation or a micro hemorrhage.  I am waiting to set up an appointment to see a Neurosurgeon.
After taking the vaccine, go home felt itchy inside. Went to sleep. Woke up the next morning, had fever, freezing cold, muscle aches, sweating, headache, joint pain, could barely walk. Went to the doctor the next day. Was tested for Covid, strept throat, and flu, came back negative. Went and was tested again, results were negative. Went home with no medicine. Drink a lot of water and keep taking Tylenol. The next morning, she felt fine.
Reports that he developed lip swelling after receiving the Tdap injection 3 days ago. No difficulty with breathing. The lip swelling has now improved. Presents for further eval. PE shows mild swelling of the lower lip. Otherwise all other systems are normal. He is currently in no distress and is able to breathe normally. May be related to the vaccine he received on 10/26. Will treat with a course of BENADRYL.
Patient came back on 12/23/11 complaining of soreness of arm (cannot lift arm), had to take ALEVE everyday for soreness.
Pt. c/o sudden onset of severe aching in arm. Pt. reports arm became cold to touch for 6 hrs. with c/o stomach ache, nausea, diarrhea et HA of sudden onset.
Dark pink, tenderness, slight induration 3.5 inches x 2.5 inches at site. Tx: Prednisone, ice/heat compresses.
Petechial, bullae reaction rapidly progressing. Found to have platelet count non detectable with normal platelet count 172,000 two weeks before. Hospitalized. Treated with platelets, steroids, etc.
(2/25/2021) PATIENT REPORTS TO OFF-SITE COVID-19 VACCINE CLINIC. PATIENT FILLS OUT VACCINE CHECKLIST AND IT IS NOTED THAT PATIENT HAS PREVIOUS ISSUES WITH FLU SHOT WITH A HISTORY OF TORUBLE BREATHING. TEACHING IS PROVIDED WITH PATIENT REGARDING POSSIBLE SIMILAR REACTIONS WITH COVID-19 VACCINE AND THAT SHE SHOULD STAY AT LEAST 30 MINUTES AFTER VACCINATION IF SHE WISHES TO PROCEED. PATIENT CONSENT TO PROCEED WITH COVID-19 VACCINATION. VACCINE IS GIVEN AT 1000 INTO RIGHT ARM AND PATIENT IS ASKED TO STAY FOR OBSERVATION. AT 1030 PATIENT REPORTS TO THIS NURSE ITCHING AND HIVES.  PATIENT IS OBSERVED TO HAVE HIVES COVERING BILATERAL ARMS AND CHEST.  PATIENT DENIES BREATHING TROUBLE AT THIS TIME.  EMERGENCY REACTION KIT IS BROUGHT TO PATIENT?S TABLE. AT 1032 ON CALL PROVIDER IS NOTIFIED OF REACTION AND ORDERS ARE GIVEN FOR BENADRYL 50MG IM.  THIS IS GIVEN AT 1034  RN INTO GUTEAL AND PATIENT IS OBSERVED AND VS OBTAINED.  AT 1040 PATIENT STATES HER THROAT FEELS ?SCRATCHY? AND ?TIGHT.? IT IS RECOMMENDED TO PATIENT SHE SHOULD BE SEEN IN THE EMERGENCY ROOM.  PATIENT AGREES TO THIS IF SHE IS ABLE TO DRIVE HERSELF.  PATIENT IS FOLLOWED IN HER VEHICLE TO EMERGENCY ROOM FROM OFF-SITE CLINIC (APPROX. 8 BLOCKS).  ON CALL PROVIDER IS NOTIFIED AND HOSPITAL EMERGENCY ROOM IS GIVEN REPORT FROM THIS NURSE. UPON ARRIVAL TO ER PATIENT IS SEEN PER MD.  PATIENT REPORTS SYMPTOMS OF CHEST PRESSURE, DYSPNEA, LIGHT HEADEDNESS, ABDOMINAL PAIN, RASH, REDNESS, WARTHM AND ITCHING.  PATIENT IS GIVEN 0.4 MG SUBCU ADRENALINE AND 40 MG PREDNISONE ORALLY. PATIENT IS OBSERVED IN EMERGENCY ROOM x 1 HOUR.  PATIENT REPORTS SHE IS STARTING TO FEEL BETTER.  PATIENT IS DISCHARGED TO AT 1206 FROM EMERGENCY ROOM.
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 48 year old (age at the time of vaccination 47 year old), female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A expiry: 19-SEP-2021) dose was not reported,1 total was administered on 01-APR-2021 on right arm for prophylactic vaccination. No concomitant medications were reported.  On 11-JAN-2022, the patient had symptoms of sore throat, congestion, cough, headache, tiredness and had a fever but no fever for 2 days prior to this report (suspected covid-19 infection). The patient was treating symptoms with unspecified medicine. The congestion was annoying. The patient had these symptoms for a week and was starting to get better. On 13-JAN-2022, the patient tested negative after the symptoms started and on 17-JAN-2022, the patient tested positive with rapid/home test (suspected clinical vaccination failure). On 13-JAN-2022, Laboratory data included: COVID-19 virus test (NR: not provided) Negative. On 17-JAN-2022, Laboratory data included: COVID-19 virus test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from suspected covid-19 infection, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report is associated with Product Quality Complaint: 90000212614.; Sender's Comments: V0: 20220133026-COVID-19 VACCINE AD26.COV2.S-suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
brusing around site; Swollen; Sore arm; This is a spontaneous report received from a contactable consumer, the patient. A 47-year-old non pregnant female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: Unknown), via an unspecified route of administration on the left arm on 16Mar2021 at 15:30 as single dose for COVID-19 Immunisation. Medical history was not reported. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN) and losartan (MANUFACTURER UNKNOWN). Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested positive for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. The patient experienced sore arm, swollen and bruising around site on 16Mar2021. No therapeutic measures were taken for the adverse events. The clinical outcome of the events vaccination site bruising, vaccination site swelling and painful arm were recovering at the time of this report.  No follow-up attempts are possible; information about lot number cannot be obtained. No further information is expected.
temp of 104.7 18 hrs p/vax; treatment w/APAP;
Redness, hot to touch, Swelling, Itching      Treated with ice, Benadryl and Tylenol
States her left arm hurt when H1N1 initially injected and noticed later that day that her shoulder hurt with certain movements.
Information has been received from a nurse practitioner concerning a 22 year old female who on 03-DEC-2008 was vaccinated with the first dose of GARDASIL (lot # 0947X), IM, 0.5 ml. There was no concomitant medication. On the same day the patient experienced flu like symptoms including nausea, dizziness, headache, body ache and diarrhea. The patient did not perform any lab diagnostics study. The patient sought unspecified medical attention. Additional information has been requested. This is in follow-up to report(s) previously submitted on 2/13/2009.  Follow-up information has been received from a nurse practitioner concerning a 22 year old female student who on 03-DEC-2008 at approximately 2:00 PM was vaccinated with the first dose of GARDASIL (lot # 0947X), IM, 0.5ml in the left deltoid.  After 5 hours post vaccine (on 03-DEC-2008 7:00 PM) the patient experienced fever, diarrhea, headache, dizziness, severe body aches which lasted about 24 hours.  Symptoms were improved after she began IBUPROFEN.  It did cause her to miss a final exam at college.  The patient was recovered on 04-DEC-2008.  No further information is available.
Moderna COVID-19 Vaccine EUA  Fever 101.9, Body aches, chills, Fatigue 28 hours after I received the vaccine. I also had a lot of pain at the Injection site for 72 hours after I received the vaccine. I took some ibuprofen and it helped.
suffering the discomfort; sent me to bed, it is horrible; This case was reported by a consumer via interactive digital media and described the occurrence of discomfort in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles Vaccine with an associated reaction of discomfort (received 1st dose in October 2022 and was also bedridden, refer link case US2023AMR012334).   In December 2022, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced discomfort and bedridden. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the discomfort and bedridden were recovered/resolved.   It was unknown if the reporter considered the discomfort and bedridden to be related to Shingles vaccine.     Linked case(s) involving the same patient:  US2023AMR012334   Additional Information: GSK Receipt Date: 26-JAN-2023 Reporter's Comments: This case was reported by patient via interactive digital media. The patient got the shingles vaccine in October and in December 2022 the booster, both of them sent him/her to bed for three days it was horrible. The patient said it was worth suffering the discomfort for three days than to suffer the sequelae for all life, please get the vaccine. Additional supportive information: The follow-up could not be possible as no contact details were available.; Sender's Comments:  US-GSK-US2023AMR012334:same reporter - 1st dose
Lethargic, no appetite, throwing up at 2:30 PM, again 10:30 PM.  Fever 104 (rectal) 11:30 PM continued through next day. Fever drop to 102/103 7/16/2016 continued for 2 days.  Lethargy and no appetite also continued for same period.  Unable to keep even liquids down, would throw up within 10 minutes of trying to ingest anything. From 7/14/2016 through 7/18/2016 child would randomly scream as though in pain.  Sometimes while sleeping, or just sitting/standing.  No explanation and no contributing factors. No medications were given during this time.  Baths given to reduce or help with fever.