chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Developed Bell's Palsy symptoms (right sided facial nerve paralysis) on 6/10/2019. Vaccinations were given on 6/7/2019.
canker sore on his nose; burns; hard to touch; headache; A spontaneous report was received from a consumer concerning a 67-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced a canker sore on his nose/aphthous ulcer, it burns really bad/burning sensation, headache/headache,  and hard to touch/induration.  The patient's medical history included staphylococcal infection and canker sores. No relevant concomitant medications were provided.  On an unknown date, the patient received their first of two planned doses of mRNA-1273 (Batch/lot number:not provided) for prophylaxis of COVID-19 infection.   On an unknown date, approximately 2 weeks after the vaccination, the patient developed a canker sore on his nose, it burns really bad, and gives him a headache, it was hard to touch.   Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of events, canker sore on his nose, burning, headache, and hard to touch, were unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. The canker sore is probably related to the patient's medical history of canker sores.
Incorrect Moderna product administered to patients; No Adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Incorrect Moderna product administered to patients) and NO ADVERSE EVENT (No Adverse event) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On 27-Sep-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 27-Sep-2022, the patient experienced WRONG PRODUCT ADMINISTERED (Incorrect Moderna product administered to patients) and NO ADVERSE EVENT (No Adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Incorrect Moderna product administered to patients) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Incorrect Moderna product administered to patients).    Concomitant medications were not reported. It was stated that a provider at their facility administered the pediatric COVID-19 for 6-11 years to 3 patients, instead of the bivalent booster (Lot #: 064A22A, Expiration date: 24NOV2022). The correct dosage of 0.5 mL was administered but the product was incorrect. No treatment information was provided by the reporter.
There was minimal pain with the injection. The nurse injected into the upper left shoulder area from a standing position. By the end of the day, the pain in the shoulder and arm had escalated to a level 7 out of 10.  Within 24 hours I had a substantial loss of range of motion of the shoulder. Developed a fever from 99-100 F on and off for the next week. After approx. 14 days, the pain has now radiated to the left neck and throat, and the neck is painful to the touch and swollen.  Was seen by the Physician Asst. 7 days after injection for an exam to the area. P.A. noted the loss of range of motion and suggested exercises for the rotator cuff area to prevent capsular contracture and atrophy of muscle.   I have been doing those exercises 2 xs a day. Pain, numbness, and loss of range of motion are still present after 15 days.  Treatments I have been using include Tylenol/Advil, Epsom salt baths, icing, exercise and occasional Flexeral to help with the muscle spasms of the shoulder that are also ocurring.  I have had a small reduction of pain and a slight increase in range of motion, so hope to see better results as time passes. P.A. suggested this could take months to resolve and to follow up with her in another few weeks if the pain and ROM had not improved significantly, for possible future testing (i.e., MRI).
Immunization received 9/28/2016 24 hours after injection the left arm injection site is red and tender area approx 25 cent size. 48 hours after injection the area of redness and tenderness has doubled. tx - warm compress. TYLENOL of NSAID.
Developed weakness in both legs. Could hardly walk approximately five days post vaccination. Gradually got better after approximately one month. Muscles in legs remain slightly tingly. *F/UP report 4/1/03: A doctor's note has the following: Fatigue, malaise, hypertension, pre-diabetic state, hypothiroiditis, polymyalgia after flu shot.*
F I woke up to severe pain in my upper left arm at the same site in which I had received my Moderna booster.
This child was getting his shots as part of a catch-up series.  Two injections were given in each leg by two practitioners, doing them simultaneously for the first pair and simultaneously for the second pair of vaccines.  Between the first and second vaccine, the child began to fuss and his arm got loose.  After the vaccines were over and as one practitioner was leaving the room, that practitioner noticed own left hand bleeding from a scrape approx. 3 inches long.  We are not sure but it seems a vaccine needle caused the scrape to the practitioner which was not felt or noticed during vaccination.  No injury to the patient.
A report has been received from a Physician concerning a 5 year old male patient. The patient's medical history included asthma, bronchitis, frequent ear infections and eczema. Concomitant medications included salbutamol sulfate and salbutamol. The patient received FLUMIST quadrivalent on 20-Sep-2011 without any side effect. Further patient received another dose of vaccine with lot number BK2062 and expiry date 20-Jan-2014. The patient experienced tightness in the chest, wheezing, his stomach was hurting, and fatigue which started in the evening after administration of FLUMIST on 04-Nov-2013 and coughing. Patient's pulse oxygen on room air was 97%. The prescribed treatment included: albuterol for 2 days and ORAPRED for 5 days. He had received FLUMIST in the past and no issues were documented after receiving the 2011 dose. Action taken with FLUMIST was not applicable. At the time of reporting, the event of tightness in the chest, wheezing, stomach hurts and fatigue were ongoing and the outcome of the event of coughing was unknown. The reporter considered the events of tightness in the chest, wheezing, stomach hurts and fatigue to be non-serious and company physician identified the event of coughing and assessed it as non-serious.
Generalized tonic seizures, flailing of arms, grinding of teeth, lasted 4 minutes. No more seizures since then. Usual frequency of seizures one every 3 months, usually not that intense
Red, tender hard area immediately around injection site, and additional 6 inches in diameter lighter pink circle around the injection site. The center area itches and is painful to touch.
severe fatigue; weight loss; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A male patient in his 70's received bnt162b2 (COMIRNATY), administration date Jan2021 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious) with onset 2021, outcome "recovering", described as "severe fatigue"; WEIGHT DECREASED (non-serious) with onset 2021, outcome "recovering", described as "weight loss".  Additional information:  Reporter Contact Information: (Name withheld) is the patient. I spoke with him for the first time after many years and he relayed his experience. I asked him to request his attending physician contact Pfizer with the details. Approximately 3 weeks following (Name withheld) dose of Comirnaty in Jan2021 he experienced severe fatigue and weight loss requiring investigations and follow up by his attending physician. This has taken many months to resolve and now 1 year later describes himself as 95% back to normal. Physical details hopefully will be provided by his physician- he is a male in his mid-seventies of medium height and build and in otherwise good health - as far as I know. Optional Information: I did not probe deeply into his medical background but have requested he ask his physician to provide all to Pfizer.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Within 4 hours SEVERE stomach pain that continued for 12 hours and included 12 hours of vomiting and diarrhea. Chills off and on for 24 hours Stomach pain continued but more moderate for 48 hours
Positive COVID test after Vaccine and booster; Positive COVID test after Vaccine and booster; Positive COVID test after Vaccine and booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32 year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administered in arm right, administration date 14Oct2021 (Lot number: EW0217) at the age of 32 years as dose 3 (booster), single, intramuscular, administered in arm right, administration date 15Feb2021 (Lot number: EL3247) as dose 2, single and intramuscular, administered in arm right, administration date 26Jan2021 (Lot number: EL3247) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: IMMUNISATION (medically significant) with onset 14Oct2021, outcome "unknown", VACCINATION FAILURE (medically significant) with onset 16Jan2022, outcome "unknown" and all described as "Positive COVID test after Vaccine and booster"; COVID-19 (medically significant) with onset 16Jan2022, outcome "recovering", described as "Positive COVID test after Vaccine and booster". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (16Jan2022) positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19. Clinical Course: Patient had been tested for COVID-19, Since the vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19.The patient had no known allergies.
This spontaneous pregnancy report was received from a consumer refers to her daughter, a currently 17 year old female patient with hay fever. There was not pertinent medical history. On 25-JUN-2015, the patient was vaccinated with the first dose of GARDASIL, (dosage, route, lot# and expiration date were not reported). There were not concomitant therapy. The patient's mother reported that on an unknown date her daughter was pregnant after received GARDASIL. At the time of this report there were not laboratory diagnostic studies performed and the patient did not seek medical attention. The patient's mother explained that her daughter would be seen by her physician on an unspecified date. The last menstrual period (LMP) at the estimated date of delivery (EDD) were not reported. The outcome of exposure during pregnancy was unknown. Additional information has been requested.
Headache, Myalgia, Sore arm at injection site. Chills.  Narrative: Per employee report: Today (2/26) aching all over, very sore arm at injection site, chills and headache. Denies fever."
41/2 wx4 long area of edema and irritation on left arm. Childrens BENADRYL 12.5mg given po x one per day and ice applied.
10/24/2001, PM, the patient experienced swelling and pain. On 10/25/2001 the patient had an exam. The patient had a hot, swollen, reddened area, 3cm x 1 cm at the injection site.
I noticed my left leg burning about a week after the vaccine. It started off as a blotchy rash, but eventually started into turn into clusters that had liquid filled bumps that burned. I also noticed an uptick in my GERD and my dormant scalp psoriasis started to flare up. I contacted my medical practice, via email with photos of the rash, They initially suggested it could be dermatitis, but I started to develop extreme fatigue and was concerned I was having an autoimmune reaction to something. The rash clearly was not a bug bite or contact dermatitis and eventually I went to see my provider because I was struggling to exercise and my fatigue wasn't improving and was compounded with aches and pains. Because I didn't see my provider in person until the rash was mostly scabbed over, we did a swab for shingles, but she isn't confident it will test positive, although it does appear that I am suffering from shingles. I know shingles can be stressed induced, but I haven't been suffering extreme stress to trigger shingles and am concerned I am having an autoimmune reaction to my booster. I also articles about petechial rashes trigged by the COVID vaccine, which I shared with my provider in the event that is what triggered my rash/physical response.
awesome, like an energy boost; This is a spontaneous report from a non-contactable consumer. This consumer reported similar event for two patients. This is the second of two reports (friend of reporter's sister). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration, on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date after the BNT162B2 vaccine, the patient felt "awesome, like an energy boost". The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021240905 Same reporter and suspect drug, similar event; different patient.
Parent reports, post vax, later that evening, right leg became red and inflamed the size of a tennis ball. MD was notified at this time. Approximately 2 days later, redness and swelling resolved.
Allergic reaction; This is a spontaneous report from a contactable Other HCP. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced allergic reaction on an unspecified date. Event outcome was unknown.  Information on Lot/batch number has been requested.
Near passing out with shortness of breath when going sitting to standing. Splinter hemorrhages under fingernails
I woke up the next day with a bad headache and later I got a fever of 100.7 and the chills. The next day the fever went away, but I was real tired, and still had a slight headache. I didn't bounce back for several weeks, and I developed bronchitis, sore throat and I had a fever of101.4.
COVID vaccine breakthrough case  booster dose had 2 different listed lot numbers in Regulatory Authority  dose 1 Pfizer 2/3/21 EN5318 dose 2 Pfizer 2/24/21 EN61958
Around 12 hours after getting the shot, I started to have fairly severe muscle pain all over my body. This lasted for around the next 20 hours. I also developed a large rash around the same time just below the injection site. it has spread to the inside of my arm and covers my bicep. It is warm to the touch and irritated. As of this morning it is still there and just as large.
HIGH BLOOD SUGAR; DIZZINESS (LIGHTHEADED); INJECTION SITE PAIN; HEADACHE; This spontaneous report received from a consumer concerned a 30 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included type 1 diabetic (28 years), hypothyroidism, and down's syndrome. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1805018 expiry: UNKNOWN) dose was not reported, administered on 11-MAR-2021 on right are for prophylactic vaccination. Concomitant medications included insulin glargine for high blood sugar, and insulin lispro for high blood sugar.  On 11-MAR-2021, the patient experienced injection site pain and headache. On 12-MAR-2021, he experience high blood sugar and dizziness (lightheaded). His blood  sugar kept on increasing (400). Therefore, his therapy dose of Humalog was increased, which was not seems to be working. At the time of reporter, the reporter mentioned that, the reporter has contacted the endocrinologist and his response was awaiting and his (the patient's) all blood sugar levels recorded on the Dexcom. Laboratory data (dates unspecified) included: Blood sugar increased (NR: not provided) 400. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizziness (lightheaded) on 12-MAR-2021, injection site pain on 13-MAR-2021, and headache, and had not recovered from high blood sugar. This report was serious (Other Medically Important Condition).; Sender's Comments: 20210333817-COVID-19 VACCINE AD26.COV2. S- High Blood Sugar. This event is considered not related. The event 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 than the drug. Specifically: MEDICAL HISTORY, UNDERLYING DISEASE.
Patient is a 38-year-old female who presented to the emergency department of a local Hospital 01/18/2022 for evaluation of altered mental status.  She had been experiencing headaches for about 2 weeks that were getting progressively worse.  She was also having blurry vision and vomiting.  She was also having slow processing and delayed responses with word finding difficulties.  She was also having difficulty with memory and was "acting odd" according to her mother who accompanied her to her emergency department visit. Denied recent medication changes. She denied upper respiratory symptoms including fever or chills.    Imaging work-up was completed. Patient was admitted to a local Hospital 01/18/2022 for further evaluation of her symptoms.  She was initiated on heparin with concern of stroke.  She was also administered perflutren lipid microsphere. She was continued on her home medications of atorvastatin.  She also had orders for per requested needed acetaminophen, bisacodyl, and down sertraline, and sodium chloride 0.9% fluids.  Imaging results as noted below.  Patient symptoms resolved during her hospital stay.  She was transitioned from heparin to apixaban and discharged home with apixaban as a new medication.
BODY ACHES; SHAKING; CHILLS; FEVER; This spontaneous report received from a parent concerned an 18 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, and expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 10-APR-2021, the subject experienced body aches. On 10-APR-2021, the subject experienced shaking. On 10-APR-2021, the subject experienced chills. On 10-APR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chills, fever, body aches, and shaking. This report was non-serious.
Information has been received from a physician who reported that her mother was talking with her friend, a probably 75 year old patient who was vaccinated with a dose of zoster vaccine live (Oka/Merck). Subsequently the patient experienced a rash. At the time of the report, the patient's outcome was unknown. This is one of several reports received from the same source.
swelling on his face and lip; swelling on his face and lip; hives all over his body; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (swelling on his face and lip), LIP SWELLING (swelling on his face and lip) and URTICARIA (hives all over his body) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.  Concomitant products were not provided.  On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, the patient experienced SWELLING FACE (swelling on his face and lip), LIP SWELLING (swelling on his face and lip) and URTICARIA (hives all over his body). At the time of the report, SWELLING FACE (swelling on his face and lip), LIP SWELLING (swelling on his face and lip) and URTICARIA (hives all over his body) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.    Treatment products included Benadryl.   Reporter did not allow further contact
Left thigh welted, itchy, red, swollen tx'd with hot washcloths, calamine lotion
Chills; sweats; body aches; headache; arm hurts; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 28Sep2023 at 10:45 as dose 1, single (Batch/Lot number: unknown) at the age of 42 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Celiac" (unspecified if ongoing); "Gluten" (unspecified if ongoing), notes: known allergies: Gluten. The patient took concomitant medications. The following information was reported: CHILLS (non-serious) with onset 29Sep2023, outcome "recovering"; PAIN IN EXTREMITY (non-serious) with onset 29Sep2023, outcome "recovering", described as "arm hurts"; PAIN (non-serious) with onset 29Sep2023, outcome "recovering", described as "body aches"; HEADACHE (non-serious) with onset 29Sep2023, outcome "recovering"; HYPERHIDROSIS (non-serious) with onset 29Sep2023, outcome "recovering", described as "sweats". Therapeutic measures were not taken as a result of chills, hyperhidrosis, pain, headache, pain in extremity.  Additional information: No other vaccine was received within four weeks but patient received other medications in two weeks. Prior vaccination, no COVID-19 and post-vaccination, no COVID-19 test was positive.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Vomiting, followed by recurrent afebrile seizures, some with localizing signs. 06/08/06-2 page gastroenterology consult of 12/12/05-Impression:Probably fatty acid metabolic disorder which has yet to be diagnoses. Plan: Follow-up on metabolic workup. 2 page DC summary 5/8/06-ED observed 2 additional seizures. In route to hospital generalized tonic clonic seizure observed. Afebrile during initial seizure episode and afebrile during hospitalization. Post vaccine and prior to onset of seizures, parents had discontinued nightly cornstarch feeding. HX significant for profound hypoglycemia and an undiagnosed metabolic disorder. Neurology consult recommended Keppra for seizure control. On day 4 of hospitalization developed vomiting and diarrhea and that symptoms were most likely viral. DC medications included Diastat for seizures lasting longer than 3 minutes.