chrisvoncsefalvay/vaers-outcomes huggingface dataset:
One day following immun was eating solid food poorly but otherwise was fine. Subsequent day woke up lethargic & was admitted to hosp for eval.
Immediately following vaccine & last three days was a deep soreness in the arm of the injection site. This side effect was anticipated. However, since then, what feels like a tightness or pinched nerve sensation has continued in that arm. It has been over one month since the vaccination. It is mildly painful to raise that arm. No degree of stretching or exercise has relieved this pain. My concern is that it may be permanent.
patients second dose of Moderna Vaccine was given at 22 days instead of the minimum of 24 days. (2 days early)
Rhabdomyolysis- CK levels in the 1800s Had to get admitted into the hospital and get iv drips to flush kidneys.
Extremely irregular periods after receiving both doses. Irregular periods still persisting in September of 2021 after getting the first dose of the vaccine in March of 2021 and second dose in April 2021.
Fever, muscle aches, & left axillary pain within 4-6 hours of injection. Fevers 101-102F,  chills, extreme fatigue, headache, nausea, diarrhea, lack of appetite,  & worsening myalgia extending from 10/13/21-10/15/21. On evening of 10/15 I began experiencing slight dizziness which dissipated before going to bed, but then noticed a golfball sized, round,  pink, tender, area noted at injection site. The next morning the site enlarged to slightly smaller than tennis ball sized, now warm to the touch, pink-red, swelling, and continued to be itchy & tender, not completely disappearing until 10/26.  On Saturday morning 10/16/21, I began experiencing worsening dizziness &  headache, to the point I was unable to look downward or turn my head more than a couple degrees side to side without the room spinning and feeling off balance.
Itchy rash, redness, minor swelling treated first with vaseline & next with alcohol swab.
2" x 7" reddened, swollen area painful to touch.  Benadryl, Motrin. Site reaction at left arm.
Red, swollen and painful by 3 pm 1/16. Got shot 1/15 at 1:30 pm.
Vomiting 2 wk since day of immun swollen, red inject site, temp 102 since day of immun;
Swollen injection site with welts. Next morning, rash started and has gotten bigger, spreading.
pt started crying 15 mins p/vax wer given on 9JUN92 & crying continued for 3-4 hrs; pt fell asleep then was awake @ 1AM; pt irritable; seen in clinic;
Shot immediately started stinging.  My upper arm swelled with a hard ridge about 3 inches long and 1 inch wide.  Extremely painful.  Could barely raise my arm and could not sleep on that side or tolerate even soft touch of my entire upper arm.  No other reaction that seemed like an allergic response.  I did get very sick for 2 days with severe flu symptoms and strange shooting pains in random parts of my body.  Enough pain to wake me from a sound sleep.  Bad chills, but no fever. I did. I give my legs seemed swollen for about 3 days.   I got the J&J vaccine on 3-6-21 and my arm is still swollen with a slightly smaller hard and painful ridge at the injection site and it sometimes throbs and itches severely.  Today is 4-2-21.  Starting to wonder if it will ever go away.  I still cannot sleep on that side.  The pain overall is less, but it still throbs and itches periodically throughout the day.
TRANSPARENT URINE; MILD HEADACHE; This spontaneous report received from a consumer concerned a 47 year old male. The patient's concurrent conditions included weight loss, and high blood pressure. The patient received covid-19 vaccine (suspension for injection, route of admin not reported and batch number: 205A21A expiry: UNKNOWN) dose was not reported, administered on 22-MAY-2021 for prophylactic vaccination. Concomitant medications included amlodipine/telmisartan for high blood pressure, and empagliflozin/metformin hydrochloride for weight loss. On MAY-2021, the subject experienced mild headache. On 22-MAY-2021, the subject experienced transparent urine. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from transparent urine, and the outcome of mild headache was not reported. This report was non-serious. This case, from the same reporter is linked.
Patient stated that the night after being vaccinated she awoke with mild fever, malaise, chills and diarrhea. This reaction significantly stronger than previous experience with vaccines, including ZOSTAVAX. Patient contacted the pharmacy at around 10am on 08/31. She reported a lingering malaise at this time, but other symptoms had subsided. She did not feel the need to have a clinic visit or be seen in an urgent setting. She did agree to contact us or go in for medical evaluation if symptoms worse or if symptoms do not resolve.
Information has been received from a nurse practitioner concerning an 11-year-old male who was vaccinated with a second dose of varicella virus vaccine live (Oka/Merck). Subsequently, the patient experienced minor varicella-like rash. Medical attention was sought. The patient's outcome was unknown. No product quality complaint was involved. Additional information from the nurse practitioner indicated that she could not remember the patient's name. No further information was available.
Facial swelling, numbness of the lower left jaw, sore throat, coughing, congestion, sneezing, headache, tenderness and soreness at injection site.
Narrative: No documentation in chart regarding tachycardia associated with Covid-19 Vaccine Moderna.
aside from chills, fever, aches I also had an anaphylactic reaction to the shot. In the evening I was exhausted and could barely move, around 10pm, I think, I started to labor with my breathing. It felt like I would stop breathing and then take 4 gasps for air, and this repeated all night and into the morning. Eventually it stopped the following day, every now and then on the following day I would repeat it but not as often.
her husband has since tested positive for Sars-cov-2; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced her husband has since tested positive for sars-cov-2. The report received as, consumer who received her first dose of Pfizer-Biontech covid19 vaccine, and her husband has since tested positive for Sars-cov-2. Her husband is quarantined in a separate room of the house, she's asking if she needs to continue to quarantine away from the rest of the world. This report type was non-serious. Outcome of the event was unknown.  Information on the lot/batch number has been requested. Follow-up attempts are completed. No further information is expected.
Starting the morning after the vaccine, patient developed a red rash around the injection site and says she has pain from the rash, came into the pharmacy today (Monday), two days after the injections and says rash has become worse.
patient returned to pharmacy complaining of unilateral pain of shoulder, neck  and tingling in finger tips.  She went to urgent care and was given a prescription for a muscle relaxer.  She is going to see her primary care doctor ,
Right arm pain / can't lay on right arm; Right arm feels like it is on fire; Hurting everywhere; Feels horrible; Dizzy when standing; Cant walk  very good; Shortness of breath; Ill; Cough; Right arm  heavy; Throwing up; Chills; Fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Right arm pain / can't lay on right arm), BURNING SENSATION (Right arm feels like it is on fire), PAIN (Hurting everywhere), FEELING ABNORMAL (Feels horrible) and DIZZINESS POSTURAL (Dizzy when standing) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003821A and 041B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 21-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2021, the patient experienced PAIN IN EXTREMITY (Right arm pain / can't lay on right arm) and LIMB DISCOMFORT (Right arm  heavy). 22-Apr-2021, the patient experienced BURNING SENSATION (Right arm feels like it is on fire), PAIN (Hurting everywhere), FEELING ABNORMAL (Feels horrible), DIZZINESS POSTURAL (Dizzy when standing), GAIT DISTURBANCE (Cant walk  very good), DYSPNOEA (Shortness of breath), MALAISE (Ill), COUGH (Cough), VOMITING (Throwing up), CHILLS (Chills) and PYREXIA (Fever). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) on 21-Apr-2021 at an unspecified dose and frequency and ONDANSETRON (ZOFRAN [ONDANSETRON]) on 21-Apr-2021 at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Right arm pain / can't lay on right arm), BURNING SENSATION (Right arm feels like it is on fire), PAIN (Hurting everywhere), FEELING ABNORMAL (Feels horrible), DIZZINESS POSTURAL (Dizzy when standing), GAIT DISTURBANCE (Cant walk  very good), DYSPNOEA (Shortness of breath), MALAISE (Ill), COUGH (Cough), LIMB DISCOMFORT (Right arm  heavy), VOMITING (Throwing up), CHILLS (Chills) and PYREXIA (Fever) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided Treatment medication include Motrin and Zofran .  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.
The adverse event was mistakenly administering the Moderna vaccine to a patient below the legal required age limit to receive said vaccine. No other adverse events have taken place.
one of the patients who received the booster shot was under the age of 18 years; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (one of the patients who received the booster shot was under the age of 18 years) in a 16-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 vaccination.     No medical history information was reported.  Previously administered products included for COVID-19 vaccination: Pfizer vaccine (First and second dose). Past adverse reactions to the above products included No adverse event with Pfizer vaccine.    On 12-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Dec-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (one of the patients who received the booster shot was under the age of 18 years). On 12-Dec-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (one of the patients who received the booster shot was under the age of 18 years) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.   The reporter was unable to provide the dates for first 2 doses.  The patient did not receive any corrective treatment.
Patient experienced dizziness/lightheadedness 15 min post injection = she remained supine until sx resolved.
Tested positive for covid; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for covid) 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.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, the patient experienced COVID-19 (Tested positive for covid). At the time of the report, COVID-19 (Tested positive for covid) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Feb-2021, COVID-19: (Positive) positive. On 16-Feb-2021, COVID-19: (Negative) negative. On an unknown date, COVID-19:.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided.  No relevant concomitant medications were reported.
Initial unsolicited report received from a nurse on 31-May-2018. This case involves a child patient (age and gender was not reported) who was vaccinated dose of PENTACEL instead of DAPTACEL (batch number, expiry date, dose series, route and site of administration were not reported) on an unspecified date. It was a case of actual medication error due to wrong vaccine administered. 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 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. Documents held by sender: none.
pt became very limp & lethargic, did respond to direct stimuli; color had been poor but 02 sat was holding @ 94%; pulse good; remained lethargic x 15 mins; woke crying;
No additional AE; HCP called to report inadvertent administration of expired MMR-II to a patient. MMR-II expired on 10/07/2023 and was given to the patient on 10/13/2023.; This spontaneous report was received from a nurse referring to patient of unknown age and gender. The patient's medical history, concurrent condition, and concomitant medications were not reported.   On 13-OCT-2023, the patient was inadvertently vaccinated with expired measles, mumps, and rubella (Wistar RA 27-3) virus vaccine, live recombinant human albumin ([rHA]) (M-M-R II) injection (lot# U031359, expiry date: 07-OCT-2023; dose, route of administration, and anatomical location not reported) as prophylaxis (expired product administered). There was no additional adverse event (AE) (no adverse event).
Extreme nausea, muscle soreness, headache, high fever , neck ache, chills, that progressively got worse as the days went by. 1 week after vaccination, I had double vision, couldn't stop shaking and balance issues. Had a virtual visit with Dr, recommended going to urgent care to get checked out and do a covid-19 test. Urgent care sent me to the ER where I had another covid-19 test, blood work, head ct, chest xray and urinalysis.  All come back negative. Went home and slept for about 5 days straight, fever finally broke, double vision went away, but still had extreme nausea, muscle aches and fatigued very easily. Slowly getting better a month later, have lost between 15-20 pounds. Don't have much of an appetite, some muscle aches and fatigue still happening, but every day is a little bit better.
Felt fine at first then everything started spinning and I started vomiting that lasted 2 hours, I was dizzy and my daughter call the ambulance and they gave me meds for nausea and started IV and at hospital they did the same and gave me something for nausea which helped.
This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient. A 39-year-old female patient received BNT162b2 (BNT162B2), on 11Sep2021 as dose 1, single (Lot number: 301308a) at the age of 38 years intramuscular, in left arm for covid-19 immunization. The patient's relevant medical history included: "Is the patient a smoker/former smoker: No" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 10Dec2021, outcome "unknown" and all described as "The vaccine doesn't work/I still ended up with COVID/AE onset date was 10Dec2021". Therapeutic measures were taken as a result of drug ineffective, covid-19 includes Remdesivir. Additional information: The patient have a positive test for SARS-CoV2 and unknown if the patient have SARS-CoV2 antibodies at diagnosis. The patient was not hospitalized and was not admitted to an Intensive Care Unit. The patient has not displayed any clinical signs at rest indicative of severe systemic illness, did not require supplemental oxygen (including high flow or ECMO) or receive mechanical ventilation. The event required the initiation of new medication or other treatment or procedure which includes Paxlovid and did not take ibuprofen flonase 600 mg. It was unknown if any pre-existing diseases worsened during the SARS-CoV2 infection. The patient has not been treated with immunomodulating or immunosuppressing medications nor received any other vaccines around the time of COVID-19 vaccination. Sender's Comments: Based on the known safety profile of the vaccine  BNT162b2, a causal relation between the reported events Covid-19, Drug ineffective and the administration of the vaccine cannot be excluded.
Subsequently post vax, the pt experienced a rash. The reporter felt that the rash was related to therapy with hepatitis B vax.
Mother called today to report that patient was fine friday night after receiving vaccines. On Saturday morning, she developed a fever, throbbing headache and pain and tingling to left arm and leg. She got better on her own by Sunday, the 9th and was able to go to school on the 10th with no complains of.
2nd dose administered outside of the recommended dosing window; feeling crummy overnight; numbness in his feet which started about a month ago.; chills; fever; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose administered outside of the recommended dosing window), FEELING ABNORMAL (feeling crummy overnight), HYPOAESTHESIA (numbness in his feet which started about a month ago.), CHILLS (chills) and PYREXIA (fever) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination.     Concomitant products included LISINOPRIL, PANTOPRAZOLE, BUPROPION HYDROCHLORIDE (WELLBUTRIN), FLUOXETINE HYDROCHLORIDE (PROZAC), ROSUVASTATIN, ASCORBIC ACID, BETACAROTENE, CUPRIC OXIDE, TOCOPHERYL ACETATE, ZINC OXIDE (PRESERVISION) and VITAMINS NOS (MVI [VITAMINS NOS]) for an unknown indication.    On 04-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose administered outside of the recommended dosing window), FEELING ABNORMAL (feeling crummy overnight), HYPOAESTHESIA (numbness in his feet which started about a month ago.), CHILLS (chills) and PYREXIA (fever). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose administered outside of the recommended dosing window), FEELING ABNORMAL (feeling crummy overnight), HYPOAESTHESIA (numbness in his feet which started about a month ago.), CHILLS (chills) and PYREXIA (fever) had resolved.            Treatment medications were not reported.   This case was linked to MOD-2021-292238 (Patient Link).
Expired vaccine used; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Dec-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 10-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.
Initial report was received 06 August 2008 from a health care professional. A 54 year-old female patient with a history of codeine sensitivity, had received a Tetanus and Diphtheria Toxoids injection January 2008 (manufacturer, exact date, lot number, route and site not reported) and a few days later, she developed joint pain and fatigue. Two months later, her symptoms continued and laboratory test results showed an increased erythrosedimentation rate, ANA (+) and SCL 70 Antibody (+). The patient was seen by a rheumatologist (date and results not provided) and eight months post vaccination, she continued with symptoms of fatigue, decreased visual focus and a "debilitated condition" at the time of the report. No further information was provided.
Serum sickness (several days of fever, chills, cough, sore throat in the setting of 2w of traveling urticarial rash and generalized malaise, improved with symptomatic management.
My cold sores came back even though I was taking my medication for them. I might have to change to a different antiviral.
Chest pain-felt like it was in my heart. A stabbing, intense pain. Saw an on call NP who didn?t really know what was going on. CRP levels were over 47. Things got better by a week later and disappeared.
Information has been received from a registered nurse concerning an 8 year old Caucasian male who on 13 JUL 1999 was vaccinated with the first dose of MMR in the right arm. On 13 JUL 1999, the patient was also vaccinated with the first dose of varicella virus vaccine live in the left arm. On 03 APR 2001, the patient developed fluid filled pustules (30) and a mild fever. The patient was treated with diphenhydramine HCl for itching. The patient was given acetaminophen for the fever. Subsequently, the patient recovered from the fluid filled pustules (30), mild fever and itching. Additional information is not expected.
dark red pin size dots on the skin of arms and legs; This is a spontaneous report from a contactable 75-year-old non-pregnant Female consumer (patient) reported for herself that she received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/lot number: el9267), via an unspecified route of administration on 16Feb2021 11:00AM, at single dose in left arm for covid-19 immunization. The patient's medical history included high blood pressure, asthma, and diabetes. The patient had Known allergies: Yes.  Concomitant medications were not reported. On 17Feb2021 at 10:00, the patient dark red pin size dots on the skin of arms and legs. The patient did not take any treatment for the event. The outcome of the events was not recovered