chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient had a heart attack; This is a spontaneous report from a contactable consumer. This consumer reported for a 66 year old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection), via an unspecified route of administration in the left arm on 29Mar2021 at 09:00 (Batch/Lot number was not reported) as a single dose for covid-19 immunization. Medical history included thyroid. The patient did not had any allergies. The patient's concomitant medications included levothyroxine sodium (THYROXINE) from an unknown date. The patient did not receive other vaccine in four weeks of vaccination. Patient was not diagnosed with COVID, prior vaccination. Patient has not been tested for COVID, post vaccination. On 04Apr2021 at 08:00, the patient had a heart attack (hospitalized (Emergency room/department or urgent care), medically significant) for which treatment was ongoing and scheduled angiogram. The outcome of the event was not recovered.  Information on the lot/batch number has been requested.
Lethargic, listless, not self for 1 wk post immunization.
I had the itchy the arm on the 9th day and then 13 days later i broke out in hives. I was then put on predinisone. He told me once the hives started to disappear i could stop taking them.
Patient passed out within a few seconds of receiving his 2nd Pfizer Covid vaccine and began what looked like seizing. This lasted for 3 seconds. Vaccine given 7/20/2021 at 6:30pm. No physical injury occurred. Patient gained consciousness within  seconds. Patient still felt light headed, skin clammy to touch. Patient complained of pain in neck and kept stating he wanted to lie down. 911 was called within minutes and arrived within a few minutes. Paramedics  took patient BP. Patient understood the questions asked was able to answer them all. Patient left on the ambulance with the mother.
I took off the band aid and the skin ripped off with the band aid and two other puss bubbles busted when I put pressure to wipe liquid No odor, minimal serosanguineous Local skin reaction, dime size area drainage where skin came off & 2 fluid filled small blisters, neosporin & bandaid.
got sick; Initial information received on 26-Oct-2020 regarding an unsolicited valid non-serious case received from a consumer or non-healthcare professional via social media.  This case involves female patient (age not reported) who got sick (illness), while she received vaccine INFLUENZA VACCINE.  The patient's medical history, past medical treatment, vaccination, 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 and lot number not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  The patient developed a non-serious got sick (illness) unknown latency following the administration of INFLUENZA VACCINE.  Laboratory details were not reported.   It was not known if patient received any treatment.  The event outcome was unknown for illness.  There will be no information available on the batch number for this case.
12 year old received Moderna vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (12 year old received Moderna vaccine) in a 12-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939904) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Nov-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (12 year old received Moderna vaccine). On 19-Nov-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (12 year old received Moderna vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant and Treatment medication were reported. A 12-year-old patient received the first dose of Moderna COVID-19 vaccine on 19NOV2021 (Lot# 939904 & Exp. Date: 24MAR2022 ) instead of Pfizer.
Information was received from a lawyer regarding a case in litigation involving a male patient, age and medical history not provided. On or about 30-NOV-2012 the patient was inoculated with ZOSTAVAX vaccine at a physician office for routine adult health maintenance and the prevention of shingles. The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster. In 2016 the patient was treated by a physician for onset of a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles As a direct and proximate result of ZOSTAVAX or despite receiving ZOSTAVAX for prevention of shingles, the patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain, suffering and other damages. Additional information has been requested.
Sick as hell; Initial information received on 18-Nov-2022 regarding an unsolicited valid non-serious case received from a consumer via social media.   This case involves a patient of unknown age and unknown gender who was sick as hell after receiving influenza vaccine.  It is unknown if the patient had any medical history, concomitant disease or risk factor. The patient's past medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect influenza vaccine produced by unknown manufacturer (strength, route, formulation, batch number and expiry date: unknown) in unknown administration site for prophylactic vaccination.  On an unknown date, the patient became sick as hell (illness) (latency: unknown) following the administration of influenza vaccine.  It is unknown if there were lab data/results available.  Action taken: Not applicable.  It was not reported if the patient received a corrective treatment for the event (Sick as heck).  At time of reporting, the outcome was Unknown for the event sick as heck.
Patient did not experience any adverse events though there was an administration timing error.  A patient received a second booster shot too early.  His original booster was 1/10/2022 and the vaccine  was given again 1/13/2022.  He presented with no vaccine card though he did write on the back of the form that 3 doses had been administered to date and he stated that he received a letter in the mail from his insurance company stating that he needed to receive a booster shot and he believed that a second booster was being indicated.  Student pharmacist, administered the vaccine and a regulatory authority was not checked though it was the student?s first day and I (PharmD) had not yet reviewed the policy for when a patient does not have proof of vaccination.   Training procedures will be rewritten to have staff check the vaccination interval and brand names given via a patient?s card or a regulatory authority when administering a dose other than the first shot.  The PharmD called patient on 1/14/2022 at 10:44 am to follow up with the patient and he reports that he is feeling well with no adverse events.
Tired; Headache; febrile; This spontaneous case was reported by a patient and describes the occurrence of FATIGUE (Tired), HEADACHE (Headache) and PYREXIA (febrile) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L20A and 011J20A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to chemicals (methyl acrylates). Concomitant products included CANDESARTAN for Blood pressure, SIMVASTATIN for Hyperlipidemia, CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Nasal allergy, CALCIUM, ASCORBIC ACID (VIT C) and GLUCOSAMINE for an unknown indication.   On 30-Dec-2020 at 2:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021 at 2:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FATIGUE (Tired), HEADACHE (Headache) and PYREXIA (febrile). At the time of the report, FATIGUE (Tired), HEADACHE (Headache) and PYREXIA (febrile) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Skin test negative: negative (Negative) Patch testing came negative and physician concluded it could have been an Arthus reaction.         No current illness, historical data was reported by patient.  Treatment medication was not reported by patient.  Patient went to immunologist for patch testing to ensure she was not allergic to an ingredient of vaccine in order to schedule the second dose.    This case was linked to MOD-2021-003821 (Patient Link).
Tingling about 40 minutes after on the neck and whole dude of body radiating all the way down to the foot.  2 days later complete exhaustion lasting over 4 days
Loss of voice, Rash at the site of shot, bad night sweats, extremely tired, shot site is warm to touch and still very sore. Worried about loss of voice.
Fatigue  Headache  Muscle aches  Shivering/chills  Lethargy  Loss of appetite  Diarrhea
Pt. had fever and diarrhea 1 week prior to vaccine which resolved. Pt. afebrile at time of vaccines. Rec'd vaccines 5/16/11 - On May 19 had fever 103 degrees, very slight cough - no other symptoms. Went to ER 5/20. Labs WNL, Chest x-ray WNL - admitted to hospital.
Urticaria (generalized) occurred 2 days after vaccine and persisted x >12 days.
Drowsiness lasting periodically for 2 days, soreness around the injection site, body aches lasting 30 minutes, chills lasts periodically for over 3 hours
104.2 fever lasted for almost 24 hours; This is a spontaneous report from a contactable consumer or other non hcp. A 49-years-old female patient received bnt162b2(PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, administered in Arm Left on 11Apr2021 10:00(at 49-years of age) as DOSE 1, SINGLE for COVID-19 immunisation.  Medical history included psoriatic arthropathy. Concomitant medication(s) included ustekinumab (STELARA), ibuprofen, pseudoephedrine hydrochloride (ADVIL COLD & SINUS) and pantoprazole. Prior to vaccination, the patient was not diagnosed with COVID-19.Since the vaccination, the patient has not been tested for COVID-19.The patient experienced 104.2 fever lasted for almost 24 hours on 12Apr2021 01:30.The patient underwent lab tests and procedures which included body temperature: 104.2 on 12Apr2021 Adverse event: 104.2 fever lasted for almost 24 hours. No treatment was given for the event.The event outcome was reported as recovered on 13Apr2021 at 01:30. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
exp pain in rt shoulder still a mon /p inject - numbness in thumb, fingers rt hand. seen by OH and MD at clinic - put on ATB & anti-inflamtory, no change in sx
This spontaneous report as received from a 80 years old male patient refers to himself with CIPRO allergy, penicillin allergy and no medical history. He was subcutaneously vaccinated with ZOSTAVAX (lot# was unspecified) in approximately June 2012, "about 2 months ago". Concomitant medications included SYNTHROID, unspecified cholesterol medication and lisinopril. In approximately July 2012, "4 weeks after receiving ZOSTAVAX", he developed raised, red, itchy lesions on his arms, legs and back. He was treated with a MEDROL Dose Pack, and the lesions resolved, but then returned. The physician saw an unspecified dermatologist who prescribed an unspecified oral cortisone (30 mg daily for 1 week and then dose tapered down) medication. Symptoms resolved on this medication but returned after stopping medication. The physician was using a topical steroid with some improvement medication at reporting time, but lesions continued to recur. The physician biopsied the lesions and the unspecified dermatologist also biopsied the lesions, the results of both biopsies showed inflammation. The outcome of patient was reported as not recovered/not resolved. Additional information has been requested.
Information has been received from a certified medical assistant referring to a 61 years old patient of unknown gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On 10-NOV-2016, the patient was inadvertently given a dose of VARIVAX injection (lot # L019126, expiration date 27-MAY-2017; dose and route were unknown), instead of a dose ZOSTAVAX (wrong vaccine administered). No adverse effect was reported. Additional information has been requested.
Hives/rash first appeared near injection sight on 6/1/2021, becoming more severe through 6/9/2021. Medical intervention was sought from primary healthcare provider on 6/9/2021, whereas the hives became severe and facial swelling on the right side of the face appeared and lasted from 6/10/2021 through 6/14/2021.  It was during this time that eye irritation appeared. As of this reporting the hives are still persisting, coming in 'waves' of almost unbearable itchiness, varying between a few minutes to 3 hours, with the duration varying between a few minutes to 3 hours as well. Disrupted sleep cycles have been a peripheral side affect, caused by the hives
Information has been received from  physician's assistant concerning a 16 year old female who was vaccinated intramuscularly with a 0.5 ml dose of Gardasil. it was reported that the patient was seen in the emergency room and the patient "collapsed, experienced weakness, sensory loss in extremities and the patient could not walk" after receiving Gardasil. The patient was hospitalized and the length of hospitalization was unknown. At the time of the report, it was unknown, if the patient recovered. The reporter considered collapsed, experienced weakness, sensory loss in extremities and could not walk to be disabling. Additional information has been requested.
Patchy redness on skin below injection site.  Does not itch and there are no bumps.
I was feeling unwell; Patient was scheduled for a FLU vaccine last September 15, 2021 Pharmacist mistakenly administered; Patient was scheduled for a FLU vaccine last September 15, 2021 Pharmacist mistakenly administered; Muscle aches; Joint pain; Chills; Low grade fever; Headache; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Muscle aches), ARTHRALGIA (Joint pain), CHILLS (Chills), PYREXIA (Low grade fever) and HEADACHE (Headache) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 088D21A, 025A21A and 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included FLUVOXAMINE for Anxiety, MONTELUKAST SODIUM (SINGULAIR) and CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Seasonal allergy, PROBIOTICS NOS for an unknown indication.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Sep-2021, the patient experienced MYALGIA (Muscle aches), ARTHRALGIA (Joint pain), CHILLS (Chills), PYREXIA (Low grade fever), HEADACHE (Headache), EXTRA DOSE ADMINISTERED (Patient was scheduled for a FLU vaccine last September 15, 2021 CVS Pharmacist mistakenly administered) and PRODUCT ADMINISTRATION ERROR (Patient was scheduled for a FLU vaccine last September 15, 2021  Pharmacist mistakenly administered). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency and IBUPROFEN for Headache, at an unspecified dose and frequency. On 15-Sep-2021, EXTRA DOSE ADMINISTERED (Patient was scheduled for a FLU vaccine last September 15, 2021  Pharmacist mistakenly administered) and PRODUCT ADMINISTRATION ERROR (Patient was scheduled for a FLU vaccine last September 15, 2021  Pharmacist mistakenly administered) had resolved. On 20-Sep-2021, MYALGIA (Muscle aches), ARTHRALGIA (Joint pain), CHILLS (Chills), PYREXIA (Low grade fever) and HEADACHE (Headache) had resolved.            Patient was scheduled for a FLU vaccine last September 15, 2021. Pharmacist mistakenly administered.Moderna COVID vaccine. Case is currently under the Regional Director. Shot act as a booster but official paper works are still unavailable.
35F who presents from outside short-term facility for fevers, nausea, epigastric pain, found to be COVID+.
Patient reported redness, pain, tenderness over entire upper right arm after vaccination. Diagnosed by walk-in care MD as cellulitis.
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 63-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Mar2021 as dose 1, single (Lot number: ER8737), on 21Apr2021 as dose 2, single (Lot number: EW0170), on 23Nov2021 as dose 3 (booster), single (Lot number: FD0809) and on 03May2022 as dose 4 (booster), single (Lot number: FK9893) at the age of 63 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "total knee replacement", start date: Jan2022 (unspecified if ongoing); "Allergy: Sulfa drugs" (unspecified if ongoing), notes: Allergy: Sulfa drugs; "Allergy: gluten intolerance" (unspecified if ongoing), notes: Allergy: gluten intolerance. The patient took concomitant medications.Past drug history included: Cephalosporins, reaction(s): "Allergy: cephalosporins", notes: Allergy: cephalosporins. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (16Jul2022) Negative; (19Jul2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical information: The patient took other medication in 2weeks details included too many supplements to list, other medication in 2weeks start date: 01Jul2020, other medication in 2weeks stop date: 20Jul2022. Anti viral details: [product: COVID 19 Treatment, brand: Paxlovid, Treatment start date: 06Jul2022, treatment stop date: 10Jul2022, indication:Treatment of COVID-19].Paxlovid rebound after full recovery. Tested negative on 16Jul2022 (antigen test). Started feeling bad again (marked increase in coughing and fatigue). Tested positive again on 19Jul2022 (antigen test).Known allergies included sulfa drugs, cephalosporins, and gluten intolerance and Other medical history: total knee replacement Jan2022.
Patient developed a blood cloth in his leg and as a cosnecuence it had to be amputated.
I knew I got exposed, 8/23/2022, it was an Omicron variant, my son and my husband had it. On 8/27/2022 I had a scratchy throat, on 8/29/2022, I had a fever, chills, runny nose, scratchy throat and a bad headache. I tested myself with a COVID-9 home test on 8/30 in the morning. On 8/30/2022, I went to the urgent care at noon. The doctor did not feel she had to give me another COVID-19 test because she knew I had been exposed to COVID-19. She prescribed me the PAXLOVID. After I started the PAXLOVID on the 4th day, I was already testing negative and feeling well. Except for the PAXLOVID side effects. It had an awful metallic taste in my mouth and one day of diarrhea and then my COVID-19 came back again. On day 9 after I started PAXLOVID and I was done with PAXLOVID, I was positive again for another week. I was not feeling sick. I was just testing positive again. I tested positive for another 6 days.
lethargic; burning pain in armpit; redness if fading; large red spot on her arm 2 inches below the shot; hard little lump; slight low grade fever; arm was very sore; soreness in arm after first dose; This spontaneous case was reported by a nurse and describes the occurrence of PAIN IN EXTREMITY (soreness in arm after first dose), LETHARGY (lethargic), BURNING SENSATION (burning pain in armpit), ERYTHEMA (redness if fading) and VACCINATION SITE ERYTHEMA (large red spot on her arm 2 inches below the shot) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A and 026A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included SUMATRIPTAN SUCCINATE (IMITREX DF), OMEPRAZOLE and ZOLPIDEM TARTRATE (AMBIEN) for an unknown indication.   On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Feb-2021, the patient experienced PAIN IN EXTREMITY (soreness in arm after first dose). On 29-Mar-2021, the patient experienced LETHARGY (lethargic), BURNING SENSATION (burning pain in armpit), ERYTHEMA (redness if fading), VACCINATION SITE ERYTHEMA (large red spot on her arm 2 inches below the shot), VACCINATION SITE SWELLING (hard little lump), PYREXIA (slight low grade fever) and PAIN IN EXTREMITY (arm was very sore). At the time of the report, PAIN IN EXTREMITY (soreness in arm after first dose), LETHARGY (lethargic), BURNING SENSATION (burning pain in armpit), ERYTHEMA (redness if fading), VACCINATION SITE ERYTHEMA (large red spot on her arm 2 inches below the shot), VACCINATION SITE SWELLING (hard little lump), PYREXIA (slight low grade fever) and PAIN IN EXTREMITY (arm was very sore) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-065420 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-065420:
Over the past several months I have experienced increased anxiety and ADHD symptoms. I have developed severe mood issues before my period (PMDD). I have also seen a huge flair in all of my allergy symptoms. My period is often late (a known side effect of the vaccine). In March, I started experience a "heartburn-like" sensation in my chest and shoulder pain in the back of my right shoulder blade. This got severe enough that I was admitted to the ER to check for heart issues in September. I also saw a GI specialist and an allergist. I had an endoscopy and a CT scan. No one could tell me what was wrong. I was convinced many of my symptoms were hormone-related and sought a gynecologist who put me on BC pills. I finally saw an immunologist who believed I am having an inflammatory immune response. I am not anti-vaccine but I want the medical field to take seriously the possibility that some individuals may be having an adverse response to the vaccine; and this may be happening more slowly than an immediate reaction. Systemic inflammation can explain my mental health issues, my hormonal issues and my allergy issues.  Taking antihistamines reduced my chest and shoulder discomfort some. The sensation is worse right before my period. I am seeking another OBGYN for advice. I feel strongly this may have a connection with the vaccine because my symptoms got worse after I received my booster in December.
Redness and swelling to injection site, diarrhea, headache, palpitations, myalgias