chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I received the Pfizer COVID-19 vaccine at six 17:06. Starting at - 18:00 and for the subsequent 24 hours I felt soreness at a level of 2-3/10 at the injection site. Starting at - 19:00 the pain radiated down toward my elbow and up into my neck and base of skull. The soreness in my neck and base of skull was at a lever of 4/10. By 12/24/20 at approximately 18:00 the side effects had dissipated.
Mom called on 2/7/00, to have pt's L/arm checked. Pt was taken to urgent care & treated w/Keflex. Tenderness continued to spread & was hospitalized for IV therapy. On 2/10/00, cellulitis was resolved.
Headaches within 3 hours and hives/rash within 8 hours post vaccination
Patient presented to the ER with cough, shortness of breath and upper respiratory illness symptoms.  She was diagnosed with COVID-19.  She remains stable from a COVID standpoint.  Chest x-ray did not show infiltrates.  Patient remained on room air.  Infectious Disease was consulted.  Given her immunocompromised status, she agreed to receive remdesivir for 3 days. Also, her troponins were mildly elevated.  This was secondary to demand ischemia due to COVID-19.  Cardiology/ Dr was consulted.  Echocardiogram showed EF 60% without wall motion abnormalities.  She was started on aspirin, beta-blocker and low-dose statin.  LDL is 86. She will follow-up with cardiology as outpatient for stress test prior to her surgery for breast cancer. Patient was discharged home.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 28-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Sep2022 as dose 4 (booster), single (Lot number: GH9694) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient was taking other medications/products within 2 weeks of starting COVID-19 treatment. The patient received COVID-19 treatment with Paxlovid from 06Dec2022 to 10Dec2022.  No follow-up attempts are possible. No further information is expected.
pt recv vax 30SEP96 & 5OCT96 pt devel 12-15 vesicular lesions on an erythematous base on head, face, scalp, arm, & trunk;pt also noted itching;6OCT96 t102;sx required MD visit;pt dx w/varicella;
Muscle aches, fever, chills, increased asthma symptoms lasted 6 days, and large local reaction at site of Pneumovax (right arm) injection with redness, warmth, pain and induration for >1.5wks.
Developed 6th nerve palsy soon after receiving Flu injection. Sudden onset of binocular horizontal double vision. Exotropia Rt eye.
w/in 24hr mom noted swelling, warmth & redness @ site of DTAP
8 days following vaccine - started with a raised itchy bump  on right arm in area of injection , then rash on arm , turned to solid red area, hot , swollen , itchy.  The area was approximately 4 inches in length and 3.5 in diameter
5-5-2021:First felt tingling in left hand. 5-6-2021:Felt tingling in right hand by the evening felt tingling in the feet and arms. Went to ER, admitted to Hospital, later that evening transported and admitted to Hospital. Ran spinal tap, MRI tests unable to diagnosis. Couple days later she was paralyzed. They said they found intestinal infection, performed surgery. She didn't get better. Approx. after a week and half (10 days)the Neuro Specialist came in and said she had Guillian-Barre Syndrome. Started IVIG Treatments twice with initial starting approx 5/15,then did Plasmapheresis Treatments,every other day. No improvements. Diagnosed her with Guillian-Barre AMSAN.
(Vasovagal Response) Fainted when standing up after getting vaccine.  Hit shoulder on table.  C/o of mild pain to shoulder, but no additional complaints.  Laid down and no additional treatment needed.
It's a little warm sometimes to the touch; It was itchy; 3-4 days after slight redness at the injection site of 2 and a half inches diameter; Twinch in the shoulder; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE TWITCHING (Twinch in the shoulder), VACCINATION SITE WARMTH (It's a little warm sometimes to the touch), VACCINATION SITE PRURITUS (It was itchy) and VACCINATION SITE ERYTHEMA (3-4 days after slight redness at the injection site of 2 and a half inches diameter) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, the patient experienced MUSCLE TWITCHING (Twinch in the shoulder). On 27-Mar-2021, the patient experienced VACCINATION SITE WARMTH (It's a little warm sometimes to the touch), VACCINATION SITE PRURITUS (It was itchy) and VACCINATION SITE ERYTHEMA (3-4 days after slight redness at the injection site of 2 and a half inches diameter). On 24-Mar-2021, MUSCLE TWITCHING (Twinch in the shoulder) had resolved. At the time of the report, VACCINATION SITE WARMTH (It's a little warm sometimes to the touch), VACCINATION SITE PRURITUS (It was itchy) and VACCINATION SITE ERYTHEMA (3-4 days after slight redness at the injection site of 2 and a half inches diameter) outcome was unknown.            No relevant concomitant medications were reported. No treatment information was provided.   Reporter did not allow further contact
Vaccine administered at 2:30 pm. Patient called at 5:15 pm with tightening of chest & phlegm filled cough. She also was very hoarse. She had welts on arm and legs. Face was swollen and red; and eyes were very red. Vaccine injection site red and raised.
This case was linked with case 2012-10260 (reported by same reporter for FLUZONE). Initial report received from a healthcare professional on 29 October 2012. A 48-year-old male patient, whose medical history and concomitant medications were not reported, had received a dose of intramsucular FLUZONE vaccine, 0.5 ml pre-filled syringe (Lot number UH753AB, dose number not reported) in left deltoid on an unspecified date. After 7-10 days post vaccination, the patient presented pain radiating from injection site, stiff neck, numbness in fingers and face on the same side of the body as the injection was given. No visible redness or swelling at injection site was observed. Laboratory work was done to rule out underlying inflammatory disease. Corrective treatment was not reported. The patient's outcome was not reported. List of documents held by the sender: None. Follow-up information recevied from healthcare professional on 11 February 2013. Patient's demographics updated. The patient received FLUZONE vaccine on 08 October 2012. It was reported that, the patient saw by Primary Medical Doctor (PMD) and neurologist, had Magnetic resonance imaging (MRI) (results were not reported) completed. It was reported that, symptoms were deemed none influenza related and diagnosed as arthritis and "nerve issue". On an unspecified date, the outcome was recovered.
Injection site placed high on shoulder. Muscle pain, cannot lift arm above shoulder, lasting for more than 3 days. Treated with ibuprofen as needed.
MODERNA GIVEN INADVERTENTLY INSTEAD OF PFIZER, DUE TO AGE THIS PATIENT SHOULD HAVE RECEIVED PFIZER COVID VACCINE
appendix burst; bowel leak where the appendix attaches to the bowel; fighting an infection after getting his Appendix out; about 65 days from first vaccine dose; This spontaneous case was reported by a patient and describes the occurrence of APPENDICITIS PERFORATED (appendix burst) and LARGE INTESTINE PERFORATION (bowel leak where the appendix attaches to the bowel) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038K20A and 037A21B) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Feb-2021, the patient experienced APPENDICITIS PERFORATED (appendix burst) (seriousness criterion hospitalization). On 06-Apr-2021, the patient experienced OFF LABEL USE (about 65 days from first vaccine dose). On an unknown date, the patient experienced LARGE INTESTINE PERFORATION (bowel leak where the appendix attaches to the bowel) (seriousness criterion hospitalization) and POST PROCEDURAL INFECTION (fighting an infection after getting his Appendix out). The patient was hospitalized for 14 days due to APPENDICITIS PERFORATED. The patient was treated with Surgery (appendix removed) for Appendicitis perforated. On 26-Feb-2021, APPENDICITIS PERFORATED (appendix burst) had resolved. On 06-Apr-2021, OFF LABEL USE (about 65 days from first vaccine dose) had resolved. At the time of the report, LARGE INTESTINE PERFORATION (bowel leak where the appendix attaches to the bowel) and POST PROCEDURAL INFECTION (fighting an infection after getting his Appendix out) outcome was unknown. Not Provided      mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was temporarily withheld on an unknown date.       Concomitant product use was not provided by the reporter. Treatment medication included antibiotics for 3 weeks. The patient was on total parenteral nutrition until last Saturday (understood as 01-May-2021).  Company Comment: Based on current available information and the temporal association between product use and the start date of the events a causal relationship in unlikely.   Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: additional events reported (fighting an infection after getting his Appendix out, about 65 days from first vaccine dose); Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship in unlikely.
This spontaneous report was received from a 58 year old male patient reporting on himself. The patient concurrent conditions included diabetes mellitus, hypertension and high cholesterol. His drug reactions/allergies included shellfish allergy and codeine hypersensitivity. On 24-MAR-2016, the patient was vaccinated with ZOSTAVAX (lot # and expiry date were not reported). Concomitant therapies included HUMALOG, VASOTEC, LIPITOR, aspirin, Vitamin C, multivitamins, glucosamine and vitamin D. On 25-MAR-2016, the patient developed itch without rash. He sought medical attention and received a prescription for ATARAX. At the time of the report the patient had no recovered from the event. The reporter did not provide the relatedness of the event with ZOSTAVAX. Additional information has been requested.
Patient is experiencing redness, swelling, soreness, and localised heat at site of injection.
pt was shaking and not feeling well at 3:10pm (10 minutes after vaccine was administered at 3:00pm).  pt was given 2 oranges because pt describes having episodes of low blood sugar.  Clinical staff spoke  to mother and informed about event.
190 patients (9 different lot numbers) received a vaccine past the beyond used by date; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date).    It was unknown if patient received any other vaccines in the 4 weeks prior to the COVID-19 vaccine administration.  No concomitant medication reported. No treatment medication reported.  This case pertains to the 04th patient of the total 190 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-704335 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704335:Master case
Patient reports a raised blue/purple bruise around the injection site about the size of a coin. He noted the bruise about 2 days following vaccination, upon reaching the patient for follow up on day 4 the bruise is much improved. He called his primary doctor for advice but did not require an office visit.
Information has been received from a physician office manager concerning an 18 year old female with mitral valve prolapse and polycystic ovarian syndrome, a history of kidney stone and no history of drug reactions or allergies who on 30-JAN-2008 was vaccinated with the first dose GARDASIL (lot#: 654535/0950F) 0.5ml IM and on 31-MAR-2008 was vaccinated with the second dose of GARDASIL (lot#: 659962/1740U). Concomitant therapy included hydrochlorothiazide, Mg oxide, pyridoxine, ZOLOFT, YAZ and polycitric K crystals. In mid May 2008 the patient experienced dizziness and heart flutter. Subsequently, the patient recovered from dizziness and heart flutter. The patient sought medical attention with a telephone call. Additional information has been requested.
Headache, Myalgia, Fever, sore arm, chills, sore throat Narrative:  sore arm after the first injection on 1/8/21, Moderna vaccine. second injection at1245 2/5/2021. Moderna vaccine. By 5 pm, I had a migraine, chills and body aches. This alleviated on its own by about 9pm. On 2/6/21, had a second wave of symptoms in the afternoon, including migraine, severe joint pain limiting mobility and overall body aches, chills, sore throat, and fever. On 2/7-8/21, felt better, but injection sight hot, swollen and very tender  Other Relevant History:
Headache, fatigue, chills, dizziness, lightheadedness worsening not getting better; Headache, fatigue, chills, dizziness, lightheadedness worsening not getting better; Headache, fatigue, chills, dizziness, lightheadedness worsening not getting better; Headache, fatigue, chills, dizziness, lightheadedness worsening not getting better; This is a spontaneous report from a contactable Other Health Professional (patient). A 32-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EH9899), via an unspecified route of administration on 22Dec2020 13:30 at single dose for COVID-19 immunization. Vaccine location provided as Left arm. The patient medical history was not reported.  The patient was not allergies to medications, food, or other products. There was no other vaccine received by the patient within 4 weeks prior to the COVID vaccine. Concomitant medication included emtricitabine, tenofovir alafenamide fumarate (DESCOVY), finasteride, gabapentin. The patient experienced headache, fatigue, chills, dizziness, light-headedness worsening not getting better on 22Dec2020 14:30. The patient was not received treatment for these events. The patient did not have Covid prior vaccination. Covid tested post vaccination via Nasal Swab on 23Dec2020 was Negative. The outcome of the events was not recovered.
thrombocytopenia; This is a Literature-spontaneous report. The author reported different events for 4 patients. This is the 2nd of 4 reports.  A 59-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, batch/lot number was not reported), via an unspecified route of administration on an unspecified date (at an unspecified age) at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient was identified with "thrombocytopenia" at an unspecified time after receiving the Pfizer vaccine without additional details regarding platelet count, clinical course, or treatment. The outcome of the event was unknown.   No follow-up attempts are possible, information about batch/lot number cannot be obtained.; Sender's Comments: Based on temporal association, the contribution of the suspect drug to the onset of event thrombocytopenia cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate. Linked Report same reporter, different patient, same suspect , different event.
Fever, chills, pain at injection site, tired, nausea, tightness of throat, ear pain
Nausea - persistent, stomach ache - resolved; diarrhea - resolved after 2 weeks; joint pain (knees) - severe for 2 days; headaches - resolved; insomnia - improving slowly; appetite changes - persistal; irritability - night - sweats - persistent.
fever of 100.8 degrees; diarrhea; body aches; This case was reported by a consumer via call center representative and described the occurrence of fever in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain (1st dose received on an unknown date, refer case US2020205665).   On 11th October 2020, the patient received the 2nd dose of Shingrix. In October 2020, 12 hrs after receiving Shingrix, the patient experienced fever, diarrhea and general body pain. Rechallenge with Shingrix was positive. In October 2020, the outcome of the fever, diarrhea and general body pain were recovered/resolved.   It was unknown if the reporter considered the fever, diarrhea and general body pain to be related to Shingrix.  Additional details were provided as follows: It was reported that on 12th October 2020, 12 hours after the 2nd dose ,the patient experienced fever of 100.8 degrees and experienced diarrhea.  The reporter did not consent to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020205665:same reporter
I had a high fever of 103-104 for quite some time which eventually subsided, but I have been experiencing random bouts of high fever that will pop up out of nowhere. The fevers range from 100-104 and are accompanied by dizziness, headaches and concentration issues. I've been tested multiple times for COVID with negative results every time. I've had two bouts of illness with bronchial issues and extremely red throat.
My son was given the incorrect dose for his 2nd vaccine.  He had a headache for almost a month and an almost constant stomach pain. He was seen multiple times for the headache, testing for COVID all negative.  We just discovered that he was given the incorrect dose by reviewing his medical chart.
A non-serious report of nasal congestion, fever, sore throat, and headache has been received from a consumer concerning a 12-year-old female. No medical history nor concomitant medications were reported. The patient received FluMist on a Friday (date unknown). Four days later, the patient was sent home with a fever, headache, and severe congestion (sore throat). No outcomes for the events were provided by the reporter, The patient did not experience a rechallenge while receiving the suspect product. The reporter provided no causality assessment for the events. The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.
Patient administered expired doses of the Moderna COVID-19 vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient administered expired doses of the Moderna COVID-19 vaccine) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination.     The patient's past medical history included Fibrocystic breast disease, Cough, Contact dermatitis (Bilateral eyelids), Coccydynia, Viral upper respiratory tract infection, Hearing loss, Vitamin D deficiency, Vitamin B12 deficiency, Unspecified sleep disturbance, Urinary frequency, Anxiety, Mood disorder and Plantar fasciitis. Previously administered products included for Product used for unknown indication: Influenza on 30-Sep-2020 and Influenza on 05-Oct-2021. Past adverse reactions to the above products included No adverse reaction with Influenza and Influenza. Concurrent medical conditions included Hyperlipidemia, Drug allergy (penicillin v potassium tabs (Critical)), Drug allergy (Codeine Sulfate Tabs(critical)), Drug allergy (sulfamethoxazole-trimethoprim tabs(Critical)) and Drug allergy (Levaquin (Moderate)). Concomitant products included CLONAZEPAM for Anxiety, VALACICLOVIR HYDROCHLORIDE (VALTREX) for Cold sores, CYANOCOBALAMIN (VITAMIN B12 [CYANOCOBALAMIN]), PROBIOTICS NOS, CALCIUM and PANTOPRAZOLE SODIUM for an unknown indication.    On 10-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient administered expired doses of the Moderna COVID-19 vaccine). On 10-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Patient administered expired doses of the Moderna COVID-19 vaccine) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Liver function test: abnormal (abnormal) abnormal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   It was reported that patient had undergone breast implants, bilateral, travel medicine counseling, lab exam, observation and evaluation of suspected exposure to other biological agent. Patient was also screened for ovarian cancer, lung cancer, breast cancer, cervical cancer, osteoporosis, skin cancer, colon cancer, routine physical examination, and general physical examination. Patient was due to hemoccult or sigmoid, mammogram, breast exam, flu vax, pneumovax, and TD booster.
developed temp of 101.3 and tested positive for COVID 11/23/2021- has known exposure from wife who visited