chrisvoncsefalvay/vaers-outcomes huggingface dataset:
General malaise; Generalized pain; Fever 104; Nausea; Vomiting; Arm pain; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (General malaise), PAIN (Generalized pain), MYALGIA (Arm pain), PYREXIA (Fever 104) and NAUSEA (Nausea) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 18-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-May-2021, the patient experienced MYALGIA (Arm pain). On 19-May-2021, the patient experienced MALAISE (General malaise), PAIN (Generalized pain), PYREXIA (Fever 104), NAUSEA (Nausea) and VOMITING (Vomiting). At the time of the report, MALAISE (General malaise), PAIN (Generalized pain), MYALGIA (Arm pain), PYREXIA (Fever 104), NAUSEA (Nausea) and VOMITING (Vomiting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided. No relevant concomitant medications reported.
Extreme chills 12 hours after vaccine administration; constant state of hunger (beginning 5-6hr post administration)
Patient developed sweilling his left calf about 10-14 days after second  dose of his vaccine.  He had an ultrasound which demonstrated deep venous thrombosis of the left calf.
Phlebitis, UrticariaPruritus, INJECTION SITE SUDDENLY RED, WARM AND ITCHY ON 1/6 SEVEN DAYS POST VACCINE Narrative:
Pain in left scapular region progressively warm and debilitating, radiating to base of neck to left shoulder and arm. Med hx of asthma added from Med Record rec'd 11/10/2005. Additional medication added--Advair/sr Additional term added form med record rec'd 11/30/2005: Neuropathy/sr Discharge summary states asthma, rhinitis. msv
Rash on their front and back torso; rash on back only; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash on their front and back torso) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included letrovole for an unknown indication.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, the patient experienced RASH (Rash on their front and back torso). Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-107053 (Patient Link).
The patient was brought to Hospital on 02/16/2022 for AMS.  The patient quickly became hypercarbic, profoundly hypoxic and found to have COVID PNA.  The patient was intubated and had a prolonged course of ventilator support and was able to be extubated and was maintained on nasal cannula.  The patient's mental status did not improve and the patient had a sudden onset of hypotension, hypoxia and worsened mental status.  The family elected to make the patient DNR comfort and focus on comfort measures.  The patient expired on 03/15/2022.
Pfizer vaccine was administered outside- reported by patient- ? NO LOT NUMBER WERE SUPPLIED ----------------------------------------------------------------------------------------------------------------------------- I63.542 ACUTE STROKE DUE TO OCCLUSION OF LEFT CEREBELLAR ARTERY 9/26/2022 ATHEROSCLEROSIS OF AORTA I63.522 ACUTE STROKE DUE TO OCCLUSION OF LEFT ANTERIOR CEREBRAL ARTERY 9/26/2022 ATHEROSCLEROSIS OF AORTA
Bell's Palsy; This is a spontaneous report from a contactable consumer (patient). A 42-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot Number: ER8732), via an unspecified route of administration, administered in Arm Right on 26Mar2021 14:30 (at 42-years-old) as single dose for COVID-19 immunization. Medical history included Ankylosing Spondylitis and Iritis. Patient had no known allergies. Patient had no covid prior vaccination. Patient was not tested with covid post vaccination. Vaccination facility type was School/Student Health Clinic. Concomitant medications included certolizumab pegol (CIMZIA); brimonidine tartrate.  The patient experienced bell's palsy on 06Apr2021 08:00 with outcome of not recovered. Event resulted in Emergency room/department or urgent care. Treatment given was Methylpred Na Succinate, Prednisone, and Acycolvir.
Pregnant at time of vaccination.  Last menstrual period 3/26/21.  Two weeks pregnant at first dose on 4/10/21 and 5 weeks pregnant at second dose on 5/1/21. Estimated delivery date is 12/31/21.  5/2/21 experienced light-headedness, extreme fatigue and sluggishness over a 4 hour period and then it dissipated.  Experienced pain in tail bone around 5/15/21 not related to any fall or injury and is still ongoing at time of report. Also week of 5/16-5/21 experienced extreme fatigue, nausea and diarrhea. The week of 5/23 my right leg started randomly falling asleep after being seated normally for only 5 minutes. Around 5/30/21, I began experiencing extreme nerve pain in right side of right calf with burning, throbbing pain and itching. These symptoms would flare up at the slightest touch of clothing, sheets and even air. Expanded over a week into the right side of right foot, toes on right foot went numb and ball of foot. This last for two weeks until around 6/14. The week of 6/14 the left side of my body began to go numb starting with my leg and expanding up my left side to below my shoulder blade around the L8 vertebrae over a period of a few days. Currently, my left side is numb from below my left shoulder blade, side, under my left breast, buttocks, genitals, entire leg down through my foot. I saw primary care physician twice, obgyn, and finally a neurologist during this time frame. I had a sonogram of my right leg on 6/7 that ruled out DVT/ blood clots. Blood work on 6/7 and 6/18 that came back normal. The Neurologist diagnosed transverse myelitis at the L8 Vertebrae on 6/24/21.
10 days after my vaccine on 4/17/2021- I was driving and had my first ever episode of SVT-Subventricular Tachycardia.  It lasted approximately 40 minutes of a heart rate of 187+.  I then had a holter monitor put on on 4/22/2021.  On 4/23/2021 I had a 2nd episode of SVT.  Both times, I went to the emergency room.  I was then in Sinus Tachycardia for several days until medications would kick in.  Now waiting on my holter monitor results.  Everything that causes this, I don't do. (no stimulants, 1 cup of coffee per day)
Flu-like symptoms of Fever that progressed into severe chills and headache. Fatigue and general muscle / joint soreness, along with dizziness.
Case number PHEH2014US018879, is an initial spontaneous report received from a nurse on 19 Sep 2014. This report refers to a 16 year old female patient. Past medical history and concomitant medication were not reported. Previous vaccinations were well tolerated. She received only Men C, Y, W-135 liquid conjugate component of MENVEO (batch number: M14030), intramuscularly without being reconstituted with Men A lyophilized conjugate vaccine component on 18 Sep 2014. No adverse event was reported following this administration error.
Chills, chest congestion, chest pain; Systemic Rxn: Total body myalgias w/in 24 hrs.
Hives throughout the body, will treat with Benadryl at home but if I don?t see improvement I?ll go in to doctors office for evaluation. Janssen COVID-19 Vaccine EUA
A report has been received from Health Professional concerning a 7 year old, Female subject, who had bee receiving nasal FLUMIST Quadrivalent. FLUMIST Quadrivalent started on 20-JAN-2015. The patient was given extra FLUMIST Quadrivalent dose which started on 20-JAN-2015. The outcome of the event of extra FLUMIST Quadrivalent dose given is unknown. The report was considered to be non-serious.
I received my first shot around one month ago (4-6 weeks ago). If i don't get it right away will the first shot be invalid; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (I received my first shot around one month ago (4-6 weeks ago). If i don't get it right away will the first shot be invalid) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included Diabetes medication and High blood pressure medication for an unknown indication.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (I received my first shot around one month ago (4-6 weeks ago). If i don't get it right away will the first shot be invalid).        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
About a day after the vaccine, the lymphnode in the armpit of the right arm where the vaccination took place was tender for a few days.
Initial information received on 18-Dec-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a patient (age and gender unknown) who received vaccine PENTACEL. The patient's past medical history, concomitant medication and family history were not provided. On an unknown date, the patient received a 0.5ml dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot C5543AA, expiry date 08-Sep-2019 via unknown route in unknown administration site. It was an actual medication error due to inappropriate reconstitution technique. It was reported that staff members grabbed the HIB for PENTACEL and rehydrated it with a re-hydrant like saline instead of the DTaP mixture. Caller stated he is not sure what patient was injected with this mixture as no one has admitted to making the mistake yet but he knows it is one of 5 patients that received this mixture. PENTACEL was discovered with a missing lypholized (ACTHIB) powder dose that was given using saline diluent and not the liquid DTAP IPV portion of the PENTACEL. It was discovered yesterday on 17-Dec-2018. It was unknown whether patient experienced any adverse reaction after the injection. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender- none.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 13Mar2021 as dose 1, single (Lot number: EN6208), on 07Apr2021 as dose 2, single (Lot number: ER8733) and on 12Nov2021 as dose 3 (booster), single (Lot number: FHS028) at the age of 30 years for covid-19 immunisation. The patient's relevant medical history included: "Attention deficit hyperactivity disorder" (unspecified if ongoing), notes: ADHD. Concomitant medication(s) included: VYVANSE. The following information was reported: VACCINATION FAILURE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of suspected covid-19.Clinical course: Antiviral details: Brand: Paxlovid, Treatment start date: 21May2022, Treatment stop date: 25May2022, Indication: Treatment of COVID-19. Was the patient taking any other medications, products within 2 weeks of starting COVID-19 treatment was reported as Yes. the patient previously receive a COVID-19 Vaccine was reported as Yes. Reported Event: Rebound of symptoms after Paxlovid approx 2 days after recovery. known allergies was reported as No.  No follow-up attempts are possible. No further information is expected.
Diagnosed with shingles. Muscle aches, skin sensitivity, aggravating back pain, itchy/painful rash with blisters on chest and back. Given an antiviral, pain medication, and steroid. Lasted 2 weeks.
The day immediately following my booster, I developed muscle aches, chills, a fever (102.7) , and severe ringing in my ears (tinnitus). The symptoms persisted for two days and most cleared up on the third day. However, the ringing in my ears did not clear up and has never resolved since it started on 11/13/2022. I continue to have tinnitus around the clock. I never had any issues with ringing in my ears prior to developing this symptom while while reacting to my my booster shot.
reporting  vaccine error...pt received first dose on 3-31-22 and another dose 7-6-22 not separated by recommended interval 10 years...no adverse reaction noted
Flushed face, pt scratching cheeks and neck, c/o headache. 1350 no respiratory distress. Administered 30 mg BENADRYL oral.
Burning at injection site with fever of 101 for 2 days, generalized body aches.
Friday 11/5/21 is date I received shot around 9:15-9:20 am.  I was fine all day until 7pm.  I started feeling like I was getting a cold with a headache....I decided to take 2 tylenol and go to bed.....I was unable to sleep all night.....headache continued along with body aches followed by diahrea and some vomiting..this continued throughout the night into the morning - felt bad all day yesterday 11/6/2021.   Headache continued...took tylenol and went to bed...felt better this morning.  Drank gatorade and wanter yesterday and a few saltines...today had scrambled eggs and toast with more gatorade.
Erythema involving lateral aspect of right upper arm; warm to touch. Advised Benadryl 1.5 teaspoon TID or QID; cool compresses.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old male patient received BNT162b2 (BNT162B2), on 02Mar2021 at 12:00 as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "most families of antibiotics" (unspecified if ongoing), notes: most families of antibiotics. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: No other medications in two weeks. Known allergies: most families of antibiotics. Anti-viral details: Product: Covid-19 treatment, Brand: Paxlovid, Treatment start date: 02Dec2022 (Lot number: paa183750, Indication: Treatment of Covid-19).  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
12 days of being sick; High fever; cough; congestion; very, very severe" body aches; no sense of taste; headaches; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A 55-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number was not reported), via an unspecified route of administration on 16Mar2021 as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient reports that for a day and a half she was fine and on 18Mar2021 (Thursday) evening, she started experiencing very, very severe body aches and high fever of 101 and 102. She stated that these side effects lasted almost 5 days, with the fever subsiding, and then reports that it moved into a severe cough and congestion. She stated that these side effects lasted about 5 to 6 more days. She also reported that throughout this course of time, she had no sense of taste, which subsequently came back about a week ago. She also reported having headaches that stopped about a week ago but stated that today she has another one. Caller stated that these severe symptoms lasted for about 2 straight weeks and then reported that she started feeling like herself, only very, very run down. She stated that today she did not feel much better and more herself, but again reports having the same kind of headache she had through the course of this. Caller would like to know, based on these side effects, what to expect with her second dose of the vaccine. She was concerned that her side effects will be worse with the second dose.  The events outcome was reported as unknown  No follow-up attempts are possible. No further information is expected.
Patient was called about the new Bivalent booster vaccine and will call the office and get the new one soon.
sore arm at injection site (dissipated after 4 or 5 days); fatigue, muscle aches, shivering, low-grade fever (onset ~4 hours post-injection, and persisted ~30 hours post injection)
Ithcy Rash/hives appeared systemically over 12 hour period.  Treated with cortisone cream and benadryl.  Cleared up in order it appeared-first area was torso and armpits,  second was arms. Torso and armpits cleared up, then arms...etc.
mini stroke; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (mini stroke) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Atrial fibrillation.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CEREBROVASCULAR ACCIDENT (mini stroke) (seriousness criterion medically significant). At the time of the report, CEREBROVASCULAR ACCIDENT (mini stroke) outcome was unknown.            Concomitant medications were not reported.  The reporter stated that, the patient had receive the second dose, and experienced a mini stroke within two weeks.  Treatment medications were not reported.  Company Comment: Very limited information regarding this event has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.
Like two days with the flu; I had uncomfortable side effects to Moderna doses 1, 2 and 3; This spontaneous case was reported by a patient and describes the occurrence of INFLUENZA (Like two days with the flu) and IMMUNISATION REACTION (I had uncomfortable side effects to Moderna doses 1, 2 and 3) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Cancer (NOS) (Treated cancer). Concurrent medical conditions included Cardiomyopathy (Cardiomyopathy), Heart disease, unspecified (Heart disease), Blood pressure high (High blood pressure), Chronic sinusitis (chronic sinuses) and Seasonal allergy (Seasonal allergy pollen).   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INFLUENZA (Like two days with the flu) and IMMUNISATION REACTION (I had uncomfortable side effects to Moderna doses 1, 2 and 3). At the time of the report, INFLUENZA (Like two days with the flu) and IMMUNISATION REACTION (I had uncomfortable side effects to Moderna doses 1, 2 and 3) outcome was unknown.            No concomitant medication information provided. No treatment information provided.   This case was linked to MOD-2022-583433, MOD-2022-583436, MOD-2022-575167 (Patient Link).
Pain started on 9/8/21 around 2000.  Patient woke up with swelling and pain in shoulder, shoulder blade, and up the neck reaching ear/teeth. Reports no troubles breathing, no swelling of the tongue/lips/throat, no paralysis, no loss of sensation as of morning of 9/9/21 at 1030. Pain is a dull muscle ache type pain which makes it so patient can't utilize right arm which is the arm she received the 2nd pfizer vaccine in on 9/8/21. Patient hadn't taken any medications or tried alternative therapies to alleviate pain/swelling at the time of reporting.
I get sick from the flue; I get sick from the flue; Initial information regarding an unsolicited valid non-serious case received from a consumer (patient) via social media on 07-DEC-2020.   This case involves a patient of unknown age and gender who get sick from the flue (Illness and Influenza), while he/she received Influenza Vaccine.   The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medication was unknown.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number not reported) via unknown route in unknown administration site.   On an unknown date, the patient reported that every time the patient got a flu shot the patient got sick from the flue.  It was not reported if the patient received any corrective treatment.  Outcome of the event was unknown, at the time of reporting.  There will be no information available on the batch number for this case.
about 4hr p/vax pt started crying uncontrollably-cried x 5 1/2hr;rx APAP & Ibuprofen & APAP