chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Allergies; Asthma; This is a spontaneous report via contactable consumer (patient).  A female patient of an unspecified age received first dose of BNT162B2 (PFIZ-ER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on an unspecified date, as dose 1, single dose for COVID-19 immunization and second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on an unspecified date, as dose 2, single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was wondering if she could get the booster shot after getting the regular flu shot and what will be the interval of both shots. She also mentioned that she had asthma before and got shots for allergies on an unspecified date in 2021 but she was better now. She mentioned that her main concern was to know if she could get the booster shot since it will be 8 months in November since she had her Covid-19 Vaccine doses. Outcome of the events was recovering.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
4/6/21: No pain or soreness at injection site. 4/8/21: 36 hrs later, bilateral eye dryness commences, vision cloudy. 4/9/21: 72 hours since injection, bilateral eye dryness severe,  can no longer wear contacts. 4/11/21: Tightness in throat, chest, gums visibly receded 4/1/21: Went to opthalmalogist, diagnosed dry ey, obstructed meibomian glands, inflamed eyelids 4/26/21: Requested and received restasis and doxcycyline 50mg. 5/4/21: Received 2nd Moderna vaccine, eyes immediately worse, tear glands no longer functioning. 5/6/21: Went to opthalmalogist, Dr. was informed this can only be sudden onset of Sjogren's syndrome 6/25/21: Tested high and positive for CARBONIC ANHYDRASE VI (CA VI) IGM ANTIBODIES* (39.3)  and the PAROTID SPECIFIC PROTEIN (PSP) IGM ANTIBODIES*  (113.8) Early Sjogren's profile. Requested Dr., Opthalmologist file a VAERS for this. 7/15/21: Brain fog,insomnia, panic attacks, inflammation in eyes. Referred out, assigned an appointment in 6 months. Discussed condition with my endocrinologist (she manages my hormone replacement). Adrenal function tests ordered, initiated work with a medical group specializing in chronic illness. 9/24/21: Major inflammation flare. No longer able to work, brain fog, acute peripheral neuritis in fingers and toes, small and long bones. Acute systemic inflammation.  and with Medical Group Anti inflammatory protocol started. All physcians recommend short term disability. 10/31/21: Physicians and I submitted short term disability request. Was granted a 4 week period with extension conditional on neurology consult. I was unable to secure a consultation so I resigned my job on 11/19/21. Since 10/31/2021: Dry eye continues, peripheral neuropathy under management with anti-inflammatory protocol. 12/29/21: Second major flare, Sjogren's dry mouth and gum throbbing/pain. Gum involvement and dry mouth are new. 1/4/21: Consultation with Rheumatology Dr.   Comment: I am a profoundly healthy person, I have not had a cold, flu, or bacterial illness since 2004-. I have not missed a day of work due to illness since that date.  ***I can no longer work at my profession and have a debilitating autoimmune condition that did not exist prior to this vaccine.  Current theory: Moderna Vaccine reactivated a dormant Epstein Barr virus. **NOTE: To my knowledge, I have never had Epstein Barr, however it is considered a virus that (a) can initiate Sjogren's syndrome in chronically stressed individuals, and, (b) can be reactivated by the  COVID virus. Therefore I requested testing on 9/24/21 and had a high EBV profile was noted. Note I was previously tested for SS Antibodies in 2018 during a routine ANA panel and was found negative. Therefore this condition Did Not Exist prior to the vaccine.
More hives in the axillary zone; Rash all over the body; Severe headache; Dizziness; Pain in the arm of the injection; This spontaneous case was reported by a non-health professional and describes the occurrence of URTICARIA (More hives in the axillary zone), DIZZINESS (Dizziness), PAIN IN EXTREMITY (Pain in the arm of the injection), RASH (Rash all over the body) and HEADACHE (Severe headache) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy and Allergy. Concomitant products included LEVOTHYROXINE and MINERALS NOS, VITAMINS NOS (MULTIVITAMIN AND MINERAL SUPPLEMENT) for an unknown indication.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced DIZZINESS (Dizziness), PAIN IN EXTREMITY (Pain in the arm of the injection) and HEADACHE (Severe headache). On 24-Jan-2021, the patient experienced URTICARIA (More hives in the axillary zone) and RASH (Rash all over the body). The patient was treated with LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) at an unspecified dose and frequency. On 22-Jan-2021, DIZZINESS (Dizziness), PAIN IN EXTREMITY (Pain in the arm of the injection) and HEADACHE (Severe headache) had resolved. On 24-Jan-2021, URTICARIA (More hives in the axillary zone) and RASH (Rash all over the body) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.        Treatment for the event included diphenhydramine and fexofenadine.
No additional AE reported; while Separate Nurse had incorrectly documented the same corresponding immunization as VARIVAX; This spontaneous report was received from an advanced practice registered nurse (APRN) concerning a patient of unknown age and gender. The patient's concurrent conditions, medical history, drug reactions/allergies, and concomitant medications were not provided.   On 30-MAR-2022, the patient was vaccinated with a dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live recombinant human albumin (rHA) (M-M-R II) administered as prophylaxis, lot number T027935 with expiration date 18-AUG-2022 (dosage regimen and route of administration were not reported). The reporter stated that she correctly documented corresponding immunization as Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live recombinant human albumin (rHA) (M-M-R II) within patient's medical record, however, separate nurse had incorrectly documented the same corresponding immunization as varicella virus vaccine live (Oka/Merck) (VARIVAX) administered as prophylaxis (dosage regimen, route of administration, lot number and expiration date were not provided) (Transcription medication error). No additional adverse events were reported. Reporter gave permission to be contacted in future regarding the event.
My eyes are hurting since 3 days after the vaccine and have not stopped hurting not sure about getting the second dose
Redness and swelling to arm of injection site. Tender to touch. No c/o fatigue or feeling ill. Reaction confined to left arm from deltoid to elbow.
Approximately 2 hours after DTAP, patient complained of redness and itchiness from 2PM-6PM.  Left arm became increasingly red, warm to touch and hard.  No fever noted.  No Tylenol given or ice applied.  Saw physician on 06/07 for kindergarten PE - noted reaction.  This arm, left arm has oval sized area with multiple small blisters in center of redness.  Advised Tylenol per age and ice pack to area.  To consult with PMD re-blisters. Continues afebrile.
Neutropenia; This is a spontaneous report from a Pfizer-sponsored program, received from a contactable consumer (patient). A female patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), on unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that patient received first dose of COVID vaccine she had neutropenia. She wanted to know if Pfizer was conducting a study on immunocompromised people. The outcome of the event was unknown.  Information about lot/batch number has been requested.
Patient experienced immediate pain at injection site, followed by worsening of pain within 5 minutes of shot.  Upper arm is firm to touch and hot. Patient states she cannot raise her arm above shoulder level without severe pain
BODY ACHES; HIGH GRADE FEVER OF 103; This spontaneous report received from a patient concerned a 46 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, intramuscular, batch number: 1805018 expiry: UNKNOWN) dose was not reported, administered on 13-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 14-MAR-2021, the subject experienced body aches. On 14-MAR-2021, the subject experienced high grade fever of 103. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 103. The patient was recovering from body aches, and high grade fever of 103. This report was non-serious.
11/7/22 I started getting a severe cough with chest discomfort from coughing. I became hoarse. I went to the doctor in November and when it did not stop. I was taking over the counter medication for the cough. I went to the doctor in December and was given a prescription cough medication, an asthma inhaler and FLONASE. In January I was lethargic, coughing, chills, fever and body aches. I did two or three at home COVID tests that were all positive. I had a telehealth and was prescribed LAGEVRIO. All the symptoms went away. The coughing is continuing. I had a Pulmonary Function Test and Bloodwork which was all normal. I had a CT of the lung today, waiting for the results.
This spontaneous report has been received from a nurse referring to a 18 year old female patient. Information about concurrent condition, concomitant medication and medical history was unknown. On unknown dates, the patient was vaccinated with a series of RECOMBIVAX HB (strength, dose, route, lot #, expiration date and therapy type were not reported) during an unspecified time frame for prophylaxis. On unknown dates, when blood work was performed, the results indicated that the patient failed to seroconvert (anti-HBs antibody negative). The result of hepatitis (Hep) B core antibody IGM was not reactive; the result of Hep B surface immunity QN was L less than 5; the result of Hepatitis B Virus (HBV) genotype was not detected. The outcome of the event was not recovered. Information about treatment given for the event was unknown by the reporter. The patient had sought medical attention. The causality between the event and RECOMBIVAX HB was not reported.
I got shingles. I had lesion on my forehead on my left side (the only location) and I had  left eye twitching.  I did a telehealth appt for her to check it out. She prescribed Gabapentin but I didn't take it. There was a little bit of pain there with the lesions. It probably took a month or so for the symptoms to resolved.
Headache & Myalgia Narrative: DOSE 1-DAY 1-4 PAIN AT INJ SITE DOSE 2-DAY 1-3 PAIN AT INJ SIT;DAY 1-4-HA,FATIGUE;1/28-1/29 she was unable to work d/t symptoms
Migraine for first 24 days straight, still migraines multiple times a week. Severe neck and hip pain, vision changes, blurry vision, seeing "spots", muscle weakness, constantly dropping items, reactivated mono, fatigue, vertigo, tinnitus,  anxiety, brain fog, throat tightness, bloating, period changes, very long period, painful cramping, big blood clots, bladder pain, bladder frequency, weakness
Was April 23 and I felt strong chest pain, my primary doctor made an EKG showed PRE INFART, they sent me to emergency room There, I was in observation 24 hours and they made me a NUCLEAR TEST, it showed LEFT VENTRICULAR OBSTRUCTION HYPERTHROPHY, POSSIBLE ISCHEMIA, and sent me home follow cardiology, I got Cardiology, he made me a Catheterization, and told me I just have 30% blocked arteries and gave me treatment of Lipitor checking every three months.  FROM APRIL 23RD, I experiencing chest pain , presión around my breast, pain on my middle center back and discomfort on my upper stomach, I can?t do exercises for more than five minutes when before pre infart I was doing for 30 or 45 mnts without any complain on my heart.  IF , BEFORE COVID VACCINE PHEIZER, I never had any complain about my heart, why AFTER EIGHT DAYS ( I GOT THE SECOND DOSE PHEIZER 03-15-21) CAME ALL THESE SERIOUS PROBLEMS WIYH MY HEART!
Syncope possible seizure about 5 minutes after vaccine. Vitals stable. Refused transport to ED. Mother drove him home.
Patient noticed 2 days after the shot that she had a large (approx 2-3" in diameter) round bump where shot was administered.  Patient reported that it was hot to the touch.
The patient developed a basal cell carcinoma (skin cancer) at the Covid vaccination injection site.  Patient developed what he thought was a blister at the vaccination injection site on the Left Upper Arm in October 2021. After several months, the spot never healed and was getting bigger. He showed it to his primary care doctor who advised him to see a dermatologist (our office) for evaluation. A diagnostic biopsy was performed on the lesion on 3/22/22. The pathology report showed Basal Cell Carcinoma, nodular type.  The patient has treatment arranged for the skin cancer at the time of this writing. The patient will require a surgical procedure to treat the BCC.
Fever, Chills, Body and Joint Pain, Headache, Left arm pain and heaviness
Patient received the H1N1 vaccine injection on 10/28/09 and remembers developing a sensitivity to light and a headache on the Wednesday after her vaccine on 11/4/09. She sought medical care on 11/7/09 and was diagnosed with Shingles affecting her right cornea without facial involvement. She received treatment for two months and her symptoms resolved. She was also found to have a benign papilloma in her right breast during the second week of November. Her tumor was successfully removed on 12/7/09.
sx started 16OCT98 fever & swelling in hands, face, throat cont until 17OCT98 afternoon;had diff breathing w/o sitting up;sometimes swollen feeling in throat w/some nasal-face burned;joint pain;
Pain; Aches; tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain), MYALGIA (Aches) and FATIGUE (tired) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047A21A and 023M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In March 2021, the patient experienced PAIN (Pain), MYALGIA (Aches) and FATIGUE (tired). At the time of the report, PAIN (Pain), MYALGIA (Aches) and FATIGUE (tired) outcome was unknown.            Concomitant medication information was not provided by the reporter.                            Treatment information was not provided by the reporter.  Patient is taking other medication.   This case was linked to MOD-2021-404948, MOD-2021-404958 (Patient Link).
Lymphadenopathy; Difficulty breathing; Chest pain; Suspected cardiomyopathy.
expired Daptacel administered,No AE; Initial information was received on 07-Feb-2020 regarding an unsolicited valid non-serious case from a nurse.  This case involves a 34 month old (unknown gender) patient who received expired dose of DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE (DAPTACEL).  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS B VACCINE for prophylactic vaccination.  On 07-Feb-2020, the patient received third 0.5ml of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE (lot C5367AA and expiry date 30-Jan-2020) via intramuscular route in the thigh NOS for prophylactic vaccination.  It was an actual medication error due to expired vaccine used.  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's 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.
This is a spontaneous report from a contactable consumer or other non hcp (patient). A 70-year-old male patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: EW0191; Expiration Date: Sep2021), via an unspecified route of administration in arm right on 09Aug2021 at 18:50 (at the age of 70-years-old) as dose 1, single for COVID-19 immunisation. The medical history of the patient was reported as none. The concomitant medications of the patient were not reported. The Additional Vaccines Administered on Same Date of the Pfizer Suspect were reported as none. The AE(s) following prior vaccinations and Family Medical History Relevant to AE(s) were reported as none. On 09Aug2021, the patient experienced sore arm, increased appetite, fast heart rate and nervous about getting the shot. The patient asked if he should have been tested for Covid prior to getting vaccine. Stated he was thinking what if he had it, although he does not have any symptoms and checks his temperature every day anyway. Thought maybe they should test before, maybe should tell the higher ups and maybe it would help. Asked how do you know if they had it or not?, that it would only take a few seconds to check for a fever, and if they are running a temperature, maybe they have it and should recover. Stated that was just his opinion, to at least test to see. He said he had a sore arm and his heart rate increased for about 30 seconds and then it went away. Told it may had been because he was nervous. An hour or so later, his appetite kicked up and had an appetite like a horse. Said, that may be because he was relaxed once it was over, that it could had been mental. Stated that when he gets the second shot in 3 weeks, if he has a reaction and his heart rate increases, he will tell the girl, and that the first time, if it would have been worse or did not go away, he would had, but since it went away, figured it was gone and still here. The patient underwent lab tests and procedures which included body temperature: unknown on an unspecified date. The patient recovered from the fast heart rate on 09Aug2021, recovered from increased appetite on 10Aug2021, the outcome of the event sore arm was recovering and the outcome of the event nervous about getting the shot was reported as unknown. Follow-up attempts are completed. No further information is expected.
11/29/2016 9:15 am MENACTRA administered itchy right after shot by 6 pm very red and itchy, redness spreading. 11/30/16 Morning itchy-red, warm went to walk in clinic RX BENADRYL and cephalexin to ER at 9 PM redness spreading RX BENADRYL.
rash/ blisters to abdomen...  hydroxyzine solution 10mg/5ml  2.5 ml by mouth every 6 hours as needed prn itching
Severe Left Leg Pain,  thing started about three  hours after the shot and it so severe screaming and needed pain medicine . The next morning left work due to pain . 12/28/2020.  Physical Exam and called it sciatica but not what it was It was inflammation of left fascia lata the Tramadol 50mg  and Percocet 5 mg and Prednisone 5 days and it was better by 90% after receiving second shot  worsened  for a day then  back  90%
Patient developed temp of 100.3 and had seizure at home, per ER report mom noted seizure lasted for 2 minutes, with upper extremity shaking, facial twitching, unresponsive. Pt was well prior day but, had developed congestion and minimal cough that morning.
Nasal congestion, tightness in chest, "lump in throat", need to clear throat, headache, difficulty breathing/wheezing x ~2 hours, generalized urticaria, diarrhea (x 5 episodes over 2 day period), nausea, soreness at site of immunization, dizziness (lightheadedness) - symptoms mostly resolved within 24 hours except for soreness at site of immunization which persists.
Patient states 3 hours after receiving her flu shot she had a deep red blotchy rash all over her body with fever up to 100.5.  She was extremely itchy, it was flush with skin, not raised, looked like a sunburn.  Fever was gone about 18 hours later and rash was gone about 24 hours later.
After my first round of vaccinations, I started having monthly migraines. I am having at least once a month, around the time of ovulation/my period. This stopped happening seven months after my second dose (September). After receiving the booster in december, I have had two migraines since.
Fever started around 8:00 pm on the same day (4/24/19) Tdap was given, also had intermittent left sided chest pain, dizziness, and chest pain.  Pt presented to Health services around 2:20 the following  day (4/25/19).
Very sore arm; Swollen lymph nodes in armpit; Third dose (booster dose) administered; This is a spontaneous report from a contactable healthcare professional, the patient. A 37-year-old non-pregnant female patient received third (booster) dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF8841) via intramuscular route of administration in the right arm on 07Oct2021 at 11:00 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history and no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other medications within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EJ1685) via intramuscular route of administration in the right arm on 29Dec2020 at 09:00 (at the age of 37-years-old) and also a second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EJ3249) via intramuscular route of administration in the right arm on 19Jan2021 at 10:00 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. On 08Oct2021, the patient experienced very sore arm and swollen lymph nodes in armpit on same arm as injection. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had been tested for COVID-19. On 08Oct2021, the patient underwent Binax Now Rapid test for COVID 19 via nasal swab and the result was negative. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events very sore arm and swollen lymph nodes in armpit on same arm as injection were resolving at the time of this report.