chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient tested positive to COVID-19; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 (Patient tested positive to COVID-19) in a 75-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7145B) for COVID-19 vaccination.     Patient had no medical history relating to mentioned adverse event and both acute and chronic illnesses at the time of vaccination.  Patient did not received other vaccines given within 1 month prior to Moderna COVID-19 vaccine.  Concurrent medical conditions included Allergy to antibiotic (Allergy to unspecified antibiotics.).    On 22-Sep-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 26-Sep-2022,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced COVID-19 (Patient tested positive to COVID-19). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19, at a dose of UNK, during 5 days. At the time of the report, COVID-19 (Patient tested positive to COVID-19) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Sep-2022, SARS-CoV-2 test: (Positive) Positive.         No concomitant information provided  Patient got 1st dose of Moderna COVID-19 Vaccine on an unknown date in Jan-2021, 2nd dose on an unknown date in Feb-2021, 1st booster on 25-Oct-2021, 2nd booster on an unknown date Apr-2022 and the bivalent booster dose on 22-Sep-2022. For bivalent booster, one day later patient started to feel sore throat, cough and sneezing, and 4 days after the vaccine patient went to the doctor and tested positive to COVID-19.   Treatment given was Paxlovid during 5 days.   This case was linked to US-MODERNATX, INC.-MOD-2022-656135, US-MODERNATX, INC.-MOD-2022-656141 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-656135:Wife's case, bivalent booster US-MODERNATX, INC.-MOD-2022-656141:Wife's case
Patient fell off chair within 15 minutes of vaccination.  Patient fainted; BP dropped to 64/39.  IV started and transported to ER by EMS.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 43-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 29Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 42 years, in right arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 26Dec2020 as dose 1, single (Batch/Lot number: unknown), in right arm and on 29Jan2021 as dose 2, single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "1st and 2nd dose: Moderna/ 3rd dose: Pfizer" (unspecified if ongoing), notes: 1st and 2nd dose: Moderna/ 3rd dose: Pfizer. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 23May2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (31May2022) Negative; (04Jun2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient had no known allergies. The patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment. Vaccine lot unknown as it was not Available/provided to reporter at the time of report completion. The patient previously received a COVID-19 Vaccine. Patient previously had initial symptoms 23May2022 evening, no symptoms by 28May2022, negative antigen test on 31May2022. Patient took Paxlovid as treatment of COVID-19 from 24May2022 to 29May202 via oral route. Recurrence of mild sore throat (no fever) evening of 03Jun2022 and positive antigen test on 04Jun2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal association between the events and suspect drug BNT162B2 cannot be excluded.
experiencing shoulder, elbow and finger discomfort.  Tingling in the fingers.  Has experienced this in the past but not sure if it directly correlates with the vaccine
Headache, chills, body ache, lightheadedness, local swelling with COVID-19 mRNA vaccine IM into left deltoid. Patient took acetaminophen.
Patient not receive his 2nd dose on due date; Patient possibly getting 2nd dose outside of days 25-35 post 1st dose; This spontaneous case was reported by a physician and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient not receive his 2nd dose on due date) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient possibly getting 2nd dose outside of days 25-35 post 1st dose) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient not receive his 2nd dose on due date) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient possibly getting 2nd dose outside of days 25-35 post 1st dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient not receive his 2nd dose on due date) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient possibly getting 2nd dose outside of days 25-35 post 1st dose) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.
When I got the injection, I had arm pain for 3 months. I had bruising from injection. I saw my pulmonologist because I coughed for 21. Had CXR and took prednisone for 21 days.
Patient is 16 years old and was administered the vaccine by , pharmacist. Vaccine is approved for 18 years and older. Mother of patient stated no concern and patient was not experiencing any adverse effects other than sore arm.
Very cranky and inconsolable crying for 2 hrs with banging his head on floor.
After 5 minutes of patient getting the inmunization he felt  lightheaded, dizzy, pale and nauseous. He was alert all the time and responding to our questions. His blood pressure was low 94/79. He mentioned he was fasting and spend long hours without food , including that he was anxious regarding the inmunization. He drank a sip of orange juice and we place him on the floor by his back and his feet elevated resting in a chair. After 15 minutes his blood pressure went to normal  126/87.  He sit down  for 30-35 minutes more. We offered to call 9-1-1 but he refused. I spoked with him by the phone 4 hours later and he responded he is good.
Sore, soreness, 24 hrs Body aches, 24hrs Back and neck pain, 24 hrs Fatigue, 20 hrs  Couldn?t sleep, 10 hrs  Loopy, 8 hrs  Nauseous, 6 hrs  Bloating, stomach ache 2 hours
Hypersensitivity reaction; injection site hard; injection site hot; injection site itchy; tingling in face, shoulder, arm; whole face and tongue was numb; A spontaneous  report was received from a physician concerning a 38-year-old, female patient who experienced hypersensitivity reaction, injection site hardness, warmth, itching, numbing and tingling of the shoulder, arm and face, and whole face and tongue was numb following their first dose of Moderna's COVID-19 vaccine.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On 30 DEC 2020, the patient received their first of two planned doses of mRNA-1273 (lot/batch number unknown) in the left arm for prophylaxis of COVID-19 infection.   The patient stated that eight days after the vaccination, her injection site became hard, hot and itchy. This started to resolve 48 hours later but lasted for two weeks.  She also experienced numbness and tingling of her face, shoulder and arm.  Her whole face and tongue were numb.   Treatments of these events included Benadryl and ice.    The events, hypersensitivity reaction, injection site hardness, warmth, itching, numbing and tingling of the shoulder, arm and face, and whole face and tongue was numb were considered resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
From initial info received on 12/08/2003 from a literature report entitled "Obstacles to the Elimination of Haemophilus influenzae Type b Disease: Three Illustrative Cases" published in Pediatrics in December 2003, Volume 112, Number 6, pp. 1465-1466 regarding an adverse event, it was reported that a 3-year-old male pt received a 4th dose of Hib Vaccine (lot #, manufacturer, route and site of administration not reported) on an unspecified date at the age of 18 months. At the age of 3, on an unspecified date, he presented with a one-day history of fever and rigors. The temperature was 39.2 degrees C, and the leukocyte count was 8000 per mm3 with 88% neutrophils. He was discharged without antibiotic therapy. The pt was recalled and hospitalized the next day because a blood culture yielded Gram-negative rods subsequently identified as Hib resistant to ampicillin and susceptible to ceftriaxone. A second blood culture performed on the day of admission was sterile. Examination of the cerebrospinal fluid (CSF), including latex agglutination for Hib capsular polysaccharide antigen (obtained after 2 doses of ceftriaxone was normal. The pt received 3 days of ceftriaxone and was discharged to complete 7 days of cefpodoxime. He had previously been immunized with a Hib conjugate vaccine at 2, 4 and 6 months of age. He lived at home with his parents and did not attend day care. Immunoloic studies revealed normal total serum immunoglobulins, subclasses, and total hemolytic complement. The concentration of serum antibody to the serotype b H influenzae capsule obtained during the 2nd day of the hospitalization was 0.45 ug/mL by enzyme-linked immunosorbent assay. Two months later, the level was 2.0 ug/mL. The serum anti-hepatitis B surface antibody was in the protective range. No other info was provided and the pt's outcome was not reported. The reporter of this case is the same as for case 2003-03329.
pt recvd vax; 2 hrs later p/ dose 1, exp flu like sxs which resolved; following dose 2, exp hives & flu like sxs which resolved;
This case was reported by a other health professional via call center representative and described the occurrence of pain in arm in a 38-year-old female patient who received TWINRIX adult. On an unknown date, the patient received the 3rd dose of TWINRIX adult. On an unknown date, less than a year after receiving TWINRIX adult, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown. It was unknown if the reporter considered the pain in arm to be related to TWINRIX adult. Additional details were provided as follows: In 2015, the patient received the TWINRIX adult. In 2015, the patient experienced persistent soreness in arm. The reporter could not verify any information regarding this report. The reporter called another site to obtain additional information on the vaccination but there were no records that indicate that the event actually occurred. The reporter was requesting that this report be discarded.
Patient had a febrile seizure. Per dad he started with a low grade fever that day and developed seizure like activity (shaking uncontrolably for about 3-5 min) shortly after the fever started.
Patient came to the ED with shortness of breath, body aches, sore throat, and weakness.  Patient was admitted to the hospital for Covid and treated with remdesivir.
Moderna COVID-19 Vaccine  Developed my first every stye in my upper left eyelid within two hours after receiving my first dose. Swelling peaked on Sunday morning (4/25) with my eye half swollen shut. By Monday (4/26) afternoon I felt comfortable driving and the condition has continued to improve.
Fever up to 103, body aches and pains all over, shivering, headaches
Drug ineffective; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 69-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Jan2021 at 04:30 as dose 4 (booster), single (Lot number: EL3247) at the age of 68 years, in left arm 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 was not reported. There were no concomitant medications. Past drug history included: Keflex, reaction(s): "Allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown"; COVID-19 (medically significant), outcome "unknown", described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient did not receive any other medication in two weeks. On 06Sep2022 patient received treatment of Paxlovid for Covid-19.
Herpes zoster outbreak approx 1 week following second Pfizer dose; This is a spontaneous report from a contactable healthcare professional. A 56-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date in May2021 as a single dose for COVID-19 immunisation. The patient had no medical history reported. The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient did not receive any medications within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 26May2021, the patient experienced herpes zoster outbreak approximately one week following second dose of COVID-19 vaccination. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measure was taken as a result of herpes zoster outbreak which included treatment with valaciclovir. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event herpes zoster outbreak was unknown at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Chills; aches in bones and muscles; aches in bones and muscles; fatigue; This is a spontaneous report from a contactable consumer (parent) reported for his/her son. A 19-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 09Apr2021 at 09:00 AM (Lot number: EP6955) on the right arm as single dose for covid-19 immunization. Medical history included depressed left ventricular function due to COVID-19. Prior to vaccination, the patient had diagnosed with COVID-19. Concomitant medications included fexofenadine hydrochloride (ALLEGRA); metoprolol tartrate; probiotic; ascorbic acid, ergocalciferol, folic acid, nicotinamide, panthenol, retinol, riboflavin, thiamine hydrochloride (MULTIVITAMINS); that patient received within 2 weeks of vaccination. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 19Mar2021 at 09:00 AM (lot number: EP6955) on the right arm as single dose for covid-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. The patient experienced chills, aches in bones and muscles, fatigue; that the symptoms started late evening 09Apr2021 at 23:00. Treatment of Tylenol received for the adverse event. The outcome of the events was recovered on 11Apr2021.  No follow-up attempts are needed. No further information is expected.
Syncope.  Patient became very pale after administration and started sweating while seated.  Started complaining of having muffled hearing.  Then she started to pass out.  Was caught from falling.  Helped her concentrate on breathing and placed a cold damp cloth on the back of her neck.  When she was comfortable she was moved to an area with a fan to help cool her down.  After several minutes she regained her composure and felt fine.
On 4/1 I began to experience heart palpitations. The palpitations continued Friday 4/2, when I contacted my medical provider's text a doctor feature. I have not experienced heart palpitations on a regular basis, and these were long and sustained. The doctor recommended an EKG, which I declined. The palpitations decreased and abated the following week. They resumed about a week and a half following the 2nd pfizer injection, which I had on 4/18/21, and lasted on and off for about a week. However, I still have occasional palpitations since then.
Patient presented with prominent eye swelling. History of reconstructive surgery after left orbital floor injury secondary to trauma. Concern for seeding infection. Very mild symptoms (rhinorrhea with rare cough).
Almost syncope, laid pt. back on bed and put her feet up, Dr. came and check vitals of pt. after about 15 min pt. was doing better, all vitals were good, pt. left to go home. Dad said pt. also had same symptoms after first dose.
SAME AEs  EXPERIENCED AFTER VAX SHOT #2 (March 2021), HOWEVER THIS TIME EACH AE WAS MORE SEVERE  ?Injection site pain ?Headache ?Fatigue ?Full body muscle pain ?Chills ?Fever (101)
Joint pain, mild headaches and fatigue for 48 hours. Treated with ibuprofen 400. After 4 days a red, itching rash and pain in upper arm. Still not subsided. Treated with OTC ointment.
sore arm; hive-rash; This is a spontaneous report from a contactable consumer (patient) from a  sponsored program Support. This is the report of first dose. A 58-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 24Mar2021 as single dose for covid-19 immunisation. Medical history included before the first dose of the vaccine like 13 months ago she had the first allergy, they are related to the weather or stress (has not received a test yet). The patient's concomitant medications were not reported. The patient stated, she has an allergy rash hive-rash that started a week ago (6-7 days) it was prior to the second dose of the vaccine and the only side effect she experienced with the first dose of the vaccine was a sore arm on an unspecified date in 2021, it was very very sore she felt like someone punched her really hard, she couldn't lift her arm but it was manageable an lasted around day and a half. Patient wanted to know if there would be any interaction between steroids and the vaccine either injected (Kanalog) or oral (Prednisone therapy). She has not received a steroid yet, however she may have to get one of them after she sees her dermatologist because she has an allergy rash hive-rash. She was scheduled for 2nd dose on 14Apr2021 but she chose to reschedule it to 15Apr2021. Outcome of the events were unknown.   No follow up attempts are needed; information about lot/batch number cannot be obtained.
DTaP given thigh Tues 5/18 with raised red & itching area around injection on Sat- oral Benadryl given with relief & swelling gone by Sun.
Within a couple days of the vaccine my husband had a small TIA.  This included numbness in his left arm.  The numbness subsided.  On the 12th, the numbness returned which extended from his left ear down his left arm and down his left side to about the waist.  We took him to the ER.  A brain MRI showed he had a thrombotic stroke.
Approximately 1 month after second injection, I began having the sensation of menthol in my mouth, nose, tongue, throat, and lungs. The sensation is constant and continuous.  It seems to be getting stronger with time.
I had my second dose of Pfizer vaccine on April 12, 2021. Approximately April 14, 2021 I began experiencing ringing in my ears that in constant since that time.
Pt. complains of pain radiating down right forearm and tingling and numbness in fingers on right hand.
Site: Itching at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient discussed when going over the list she has syncope that occurs randomly. In my better judgment patient looked normal and healthy at taht time. Patient 5 min later felt dizzy and fainted for 10 sec before recovering. I called 911 and gave water while the other rph gave cold compress. Patinet recovered quickly when ambulance came but patient refused further medical care and has had history when given vaccine this dizziness occurs. Family member came to pick her up and walked without issue
MY RIGHT ARM THAT I HAD THE INJECTION DONE IS STILL VERY SORE AND AT TIMES CAN BARLEY LIFT MY ARM AS THE MUSCLE HURTS. IF I ROLL OVER TO MY RIGHT SIDE IT WILL WAKE ME UP DUE TO THE PAIN.
Red,swollen, indurated area left upper arm, approximately 6 by 4 cm
sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016C21A, 031A21A and 031A21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes and Blood pressure high.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Dec-2021, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) had not resolved.            No treatment was reported by the reporter.   This case was linked to MOD-2021-404776, MOD-2021-404786 (Patient Link).