chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Very high fever, lethargy within 7hrs of injection. Also two types of systemic rash presented, one being raised small bumps occurring within 7hrs of injection; covering entire legs, tops of feet and forearms. Additional rash too, palms of hand flat, red spots. Patient itching as well. Likewise, very runny/drippy nose and VERY red nose with watery eye discharge too. Patient Not very content.
3:00 am next day severe chills 10:00 am severe fogginess in head and neck, dizziness.  Went to ER Today is 8/22 and I?m still having headaches off and on in back of my head and neck.  Just don?t feel well.
On my final (second) shot of the Moderna, my injection site is swollen, red, and itchy.
Left eye scleritis and pain 17 days after vaccine.; Left eye scleritis and pain 17 days after vaccine.; This is a spontaneous report from a contactable nurse (patient herself).  A 58-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in right arm on 22Mar2021 11:00 (Batch/Lot Number: EP7534) (at the age of 58-years-old) as single dose for COVID-19 immunisation. The recent COVID-19 vaccine was administered in public health clinic ddministration facility. The patient medical history included Hashimoto's thyroiditis, high cholesterol, and depression, and allergies to penicillin and sulfa. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included escitalopram oxalate (LEXAPRO), levothyroxine sodium (SYNTHROID); magnesium; ergocalciferol (VIT D); all taken unspecified indications, start and stop dates were not reported.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took cephalosporin (CEPHALOSPORIN C)  and benzalkonium chloride (BAK) and experienced allergies on both. On 08Apr2021, the patient experienced left eye scleritis and pain 17 days after vaccine. The events were reported as serious due to hospitalization. The events also resulted to healthcare professional office/clinic visit and  emergency room/department or urgent care. Therapeutic measures were taken as a result of the events which included methylprednisolone dose pack. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovering.; Sender's Comments: Based on the available information and known product information, the causal relationship between the reported left eye scleritis and pain and the BNT162B2 vaccination  cannot be fully excluded. However,  reported scleritis associated with it may be  confounded by the history of thyroid disease  since non-infectious scleritis has been associated with thyroid disorders and autoimmune disease.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
lack of taste; lack of smell; fever; troubled breathing (shallow); trouble eating; A Spontaneous case  was received from consumer, concerning a female patient  of age 70, who received Moderna's COVID-19 vaccine experienced Ageusia/ lack of taste, Anosmia/ lack of smell, Pyrexia/ fever, Hypopnoea/ troubled breathing (shallow), Eating disorder symptom / trouble eating.   The patient's medical history was not provided. The Patient's concomitant medications were not provided.  On an unknown date, prior to the onset of events, the patient received her first of two planned doses of mRNA-1273 (Batch number : unknown) via unspecified route for COVID-19 infection prophylaxis  On 27Feb2021, prior to the onset of events, the patient received her second of two planned doses of mRNA-1273 (Batch number : unknown) via unspecified route for COVID-19 infection prophylaxis.  On 29Feb2021, the patient is experiencing lack of smell, taste, fever, trouble eating and trouble breathing (shallow). Oximeter reads that she is receiving enough oxygen (no specific percentage).  As the patient has already taken both the scheduled doses of the vaccine, the action taken in response to the events, Ageusia, Anosmia, Pyrexia, Hypopnoea, Eating disorder symptom was unknown.  The outcome of the event Ageusia, Anosmia, Pyrexia, Hypopnoea , Eating disorder symptom was considered to be unknown.  The treatment medications taken by the patient was aspirin.
hands are tingly; My hands are tingly and so cold.; felt terrible everyday; Nauseated; Arms felt like they were asleep; so sick; Hurt all over; not moving too fast; I do not want food; I have not eaten, taken a shower or anything; This is a spontaneous report from a contactable consumer (Patient, self-reported). A 80-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 09Feb2021 09:45 (at the age of 80-years-old) as SINGLE DOSE for covid-19 immunisation. Medical history included immunodeficiency, atrial fibrillation. The patient got her shot last Tuesday morning at 9:45 and had been real sick after this. The patient had a bad reaction to it. Well after patient got the shot it was in the. And it said if she was on blood thinner (Unspecified Medications) or 'immune disorder' (not clarified further) she know and she was both of those and was just wondering what to expect and today from elbow. On unspecified date of Feb2021 , her arms felt like they were asleep and then now it was from elbow bit down and her hands got real cold. Now she had not ran a fever and she had not vomited, but she did not want food. She had hurt all over and she had been nauseated (on unspecified date of Feb2021) but not vomited. She had not eaten, taken a shower or anything, and she had been so sick (on unspecified date of Feb2021). Well let her see if she could see a pen that writes. She was not moving too fast (on unspecified date of Feb2021). She wanted to know if this was going to affect her blood, the thickness or the firmness. Since Tuesday, 09Feb2021, patient hands were tingly and so cold. The patient had felt terrible everyday. She had other relatives that got some aches and fatigue , but nothing like what she had. The patient was not currently not taking any immunosuppressant drugs.  Patient was enquiring that was it ok to get her 2nd Pfizer vaccine vaccine dose in 4 weeks.  The patient also enquiring about was it a problem, with getting the vaccine, if she take Blood thinners, she had atrial Fib and used to get a lot of blood clots. And was there any problem with being immunocompromised and getting the vaccine. Outcome of the events was unknown.   Information on batch/lot number has been requested.  Follow-up attempts are completed. No further information is expected.
1 of 4 pts vax from the same lot exp an adverse event; pt recv OPV only 10SEP94 @ well-baby visit; 12SEP parent reported that pt had a fever of 103.2; ofc visit; 12SEP nl exam; no med prescribed;
Chills, fever of 102, lethargy, headache, body pain, subsequent ?COVID arm? at injection site 1-3 days later with itching, soreness, swelling, heat.
S1. erythematous left upper arm, slightly warm and tender. 2 days s/p DTap, flu IM injection Left deltoid and Polio SC.
A report has been received from a health professional via medical representative, concerning a male patient. Relevant medical history, concurrent diseases and concomitant medications were not reported. On unspecified date, the patient got FLUMIST (intranasal). The patient experienced severe sinus symptoms and severe headache symptoms. Action taken and the outcome of the event of sinus symptoms and headache symptoms was unknown. The company physician assessed the events of sinus symptoms and headache symptoms to be serious due to criteria of medical importance.
This spontaneous retrospective pregnancy report as received from a nurse referring to a female patient of unknown age. The patient's concurrent condition, concomitant therapy and medical history were unknown. On an unknown date, the patient was vaccinated with GARDASIL 9 (dose, frequency and route were unknown, lot # M028323, expiration date: 26-SEP-2018) for prophylaxis. The nurse reported it was unknown which dose in the GARDASIL 9 vaccination series was administered while the patient was pregnant(maternal exposure during pregnancy). The last mentrual period (LMP) and estimated date of delivery (EDD) was not known. On 30-OCT-2017, the patient delivered a baby (at unspecified hospital and unspecified location) without any side effects. The patient was no longer pregnant as of the time of report. The outcome of maternal exposure during pregnancy was recovered.
Dizziness for about a week.; Heart palpitations for about a week; "stiles while sleeping"; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EW0162) via an unspecified route of administration in the left arm on 20Apr2021 at 10:00 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. Medical history included Wolf Parkinson white diagnosed in 2014, after giving birth to her second child (pregnancy). Concomitant medications included loratadine (CLARITIN), calcium carbonate (TUMS), vitamin d nos (MANUFACTURER UNKNOWN) and ascorbic acid (VITAMIN C); all taken for unknown indications from an unknown date and unknown if ongoing. The patient previously received sulfa drugs, sulfamethoxazole; trimethoprim (BACTRIM) taken for unknown indication and experienced drug allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8733) via an unspecified route of administration in the left arm on 29Mar2021 at 14:00 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any vaccination within four weeks prior to the COVID-19 vaccine. On 21Apr2021 at 09:00, the patient experienced dizziness and heart palpitations for about a week. The patient reported heart palpitations mostly happened at night when laying down and when woke up in the morning and some stiles while sleeping on 21Apr2021. It had not been detectable though since the patient was 6 weeks postpartum and had virtually no palpitations since 6 weeks, post partum until she received the second dose. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events dizziness for about a week, heart palpitations for about a week and "stiles while sleeping" were unknown at the time of this report.
injection site reaction: sore arm x1 day   Narrative: Patient a 69 year old MALE who received the 1st of COVID vaccine 3/3/21. Spoke w/pt today RE: adverse reaction related to the vaccination.------------------------------------------------------------------------------------------- SYMPTOMS: Fever NO If yes temp: n/a Fatigue No Myalgia No Arthralgia No Rash/Hives No SOB No Bell's Palsy No Injection Site Reaction Yes Other No If yes describe: Arm soreness x1 day
A serious report of proctitis has been received from a study investigator concerning a 4-year-old female participating in a post-marketing study for FLUMIST. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. The subject's medical history and concomitant medications were not reported. On 10-Sep-2009, the subject received FLUMIST, 0.25 ml per nostril. She received a total of one dose of FLUMIST before onset of the event given on 10-Sep-2009. On 23-Sep-2009, the subject presented with a one-day history of blood in stool with diarrhea. At the exam, it was stated that she was without pain; however, elsewhere, it was stated that she had several months of abdominal pain prior to this event. The subject had no other symptoms. Five weeks prior to this exam, she had an episode of constipation when starting kindergarten. On 02-Oct-2009, she was examined for blood in stool although at that point passed blood with more formed stool and had occasional abdominal pain in right upper abdomen. She had no nausea or vomiting. On 08-Oct-2009, she was seen by the specialist and differential diagnosis included irritable bowel disease, polyps and Meckel's diverticulum. She was hospitalized on 14-Oct-2009 and discharged on 15-Oct-2009. Colonoscopy under sedation and MRI of the lumbar spine were done, and they were suggestive for proctitis and biopsies were clear. MRI was within normal limits. The event of proctitis was resolved on 15-Oct-2009. The investigator assessed the causality for the events to FLUMIST as none. The severity of the events were mild. The alternative etiology was natural. The sponsor assessed the causality for the event of proctitis as not related to FLUMIST.
12 days after receiving my first dose of the moderna Covid-19 vaccine my arm swelled up and became very red, sore, and had fever in it. A big red place has continued to spread out from the point of injection. I have felt sick to my stomach and very sore. I need to know if  I should receive the second dose of the vaccine .
Pt called: on inside of arm vaccine was given red bumps above elbow pt took 50mg BENADRYL and cooled with ice.
Full body hives, swollen throat + lips+ eyelids, severe itching, sore throat, difficult swallowing, hoarseness, tightness in throat
This case was reported by a consumer via call center representative and described the occurrence of hives in a adult female patient who received SHINGRIX for prophylaxis. Previously administered products included Shingle vaccine (received several years before the reporting date, without adverse events). Concurrent medical conditions included eye dryness. Concomitant products included RESTASIS, Simvastatin, Aspirin and MYRBETRIQ. On 10th June 2018, the patient received the 1st dose of SHINGRIX. On 11th June 2018, 1 days after receiving SHINGRIX, the patient experienced hives. The patient was treated with BENADRYL. On an unknown date, the outcome of the hives was recovered/resolved. The reporter considered the hives to be related to SHINGRIX. Additional information was received as follows: The age at vaccination was not reported. The patient reported that, around noon on Sunday, she received the SHINGRIX vaccine on left arm. The patient noticed on Monday that she had hives on her arms, bottom and back. The patient called her physician and he told her to take BENADRYL and it cleared up a little bit but came back over night. The night before reporting date, she took BENADRYL again at night and her hives cleared up in morning of reporting day.
After injection, roughly 10 minutes in, patient began to feel "foggy" in the head. Roughly 10 minutes later she then proceeded to feel cold, with shaking. The shaking lasted roughly 10 minutes then resolved. She had a decrease in heart rate that lasted foughly 5-7 minutes. ECG normal. Vitals then stayed WNL. After initial assessment, EMS was called and was transported via EMS at about 10:20 AM. She never lost consciousness and stood up and walked to the stretcher.
didn't develop any antibodies; This is a spontaneous report from a contactable nurse, the patient. This patient of unknown age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: unknown), dose 2, single dose via an unknown route of administration on 07Jan2021 for COVID-19 vaccination. Medical history was unknown. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: unknown), dose 1, single dose on an unknown date. Concomitant medications were unknown. The patient took both vaccines, last vaccine was administered on 07Jan2021 and had a significant immune response. The patient donated blood on the 24Feb2021 due to shortage in the community and just found out that "I didn't develop any antibodies." The patient was worried that the vaccine didn't work. The clinical outcome of  the event, didn't develop any antibodies was unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Extreme discomfort, swelling, raised red rash appeared the next evening(7/10/2018).
When reporting my fever Saturday I entered it incorrectly - my temperature reached 104 and I wanted to report that correctly - it cleared by Sunday morning
pt exp inc swelling & redness @ inject site extending from shoulder to elbow; area warm to touch, pt denied pains; was placed on ATB for 10 days;
Febrile beginning at 1600, 100.5 degrees, peaking at 2100, 104degrees, accompanied with tightness in chest with mild difficulty breathing and extreme muscle weakness  most notably in extremities, bilaterally. Needed assistance to stand and could not hold a pencil to write. Also numbness and tingling in hands and fingers. Face slightly swollen and red.  400 mg Ibuprofen was administered at  1530. Pushed fluids as soon as fever began. Cooling measures provided, cool shower, cold compress, change of clothes to light pajamas.  We contacted our Insurance 24 hour Nurse line at approximately 2100 when symptoms peaked. The RN on staff instructed us to seek immediate medical care.  We attempted to find an open Urgent Care unsuccessfully and tried to go to an ER but they were full. Fever began to come down around 2230, so we returned home. Continued with ibuprofen every six hours and cooling measures.
This spontaneous report as received from a register nurse refers to a 3 months infant, of unknown gender. Medical history and concurrent conditions were not reported. On 10-MAR-2014, the patient was vaccinated with first dose of ROTATEQ, lot #J007283; expiration date: 27-SEP-2014 (dose and strength were not reported. Secondary and concomitant therapies were not reported. Nurse called and stated that improperly stored ROTATEQ was administered to patient. No adverse effects reported. The nurse reported that vaccine dose received by patient was a vaccine improperly stored as follows: On 13-JAN-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 50 degrees F. On 18-JAN-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 49.1 degrees F. On 10-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 6 hours (12 pm - 6 pm) the temperature recorded was 51.8 degrees F. On 16-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 5 hours (12 pm - 5 pm) the temperature recorded was 51.8 degrees F. On 22-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 4 hours (2 pm - 6 pm) the temperature recorded was 52.7 degrees F. On 09-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (12 pm - 10 pm) the temperature recorded was 55.4 degrees F. On 15-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 6 hours (8 am - 2 pm) the temperature recorded was 50 degrees F. On 16-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 20 hours (2 am - 10 pm) the temperature recorded was 64.4 degrees F. On 17-MAR-2014, ROTATEQ the temperature reading on the morning was 64.8 degrees F. The total of hours stored outside of recommended temperatures was 55 hours. This is one of several reports from the same reporter. Additional information has been requested.
It seemed to be the usual tenderness and slight redness and puffy. Size = small a dime size maybe. Friday 10/7  Then in a few hours some itching, headache, mild temperature.Saturday 10/8 - I slept and when I woke I was REALLY itchy and looked at the sight.  It was Very red and TERRIBLY itchy and swollen and the size was about 1.5 - 1.75 inches.  It looked "mean". I took another tylenol and allegra as above. Then on Sunday 10/9 the red patch looked inflamed, itchy as before and a feeling of hives in my left hand*.   Meds taken as before.  10/10 - The size of the red spot remained about 1.5 inches. The itching lessened and while still red swelling reduced.
Fever 100.4, chills, body aches, rapid heartbeat,  chest discomfort.  Nurse advised going to ER, so did so.
Rash on upper arm. Blotchy, doesn't itch, warm to touch, no drainage, not raised. On the inner aspect of arm
sick; Initial information was received on 18-Nov-2020 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional (patient) via social media.  This case involves patient (unknown demographic) who had sick (illness), while patient received INFLUENZA VACCINE.  Medical history, medical treatment(s), past vaccination(s) concomitant medication and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date were not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious sick (illness) (unknown latency) after the administration of INFLUENZA VACCINE.  Laboratory data was not provided.  It was not reported if the patient received a corrective treatment.  At the time of reporting the outcome of event was unknown.  There will be no information available on the batch number for this case.
Large 3 inch circle around injection site, swollen, warm, itchy and lasted 3 days after injection then returned on day 7 after injection and was 4 inches wide on arm.