chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Very itchy on her arm at the place she got the vaccine shot; Hard piece of skin, when she touches it, it was not the normal skin like on her other arm, it was itchy, it was like a hard skin; This is a spontaneous report received from a contactable consumer. A 75-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: ER8737), via an unspecified route of administration on 20Apr2021 between 8:30 to 9:00 (age at vaccination was 75 years) as dose 2, single for covid-19 immunisation. The relevant medical included high cholesterol (condition for about 20 years), blood pressure (condition for 25 years) and problem with the thyroid (for 4 to 5 years, some nodules in her thyroid, had a biopsy and treated with unspecified medication), all ongoing since an unspecified date. Family history included cancer for mother, father and sister. The concomitant medications included calcitriol (ZAVITROL) ongoing since 2020 for thyroid, atenolol ongoing since 2011 for blood pressure, amlodipine besilate (AMLOPRES) ongoing since an unspecified date for blood pressure, rosuvastatin for triglyceride and high cholesterol ongoing since 2016, COLECALCIFEROL (VITAMIN D3) for bone problems ongoing since 2020 and zinc sulfate (UNIZINCO) for thyroid problem ongoing since 2021. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: ER8737), via an unspecified route of administration, administered in left arm, upper left arm on 30Mar2021 between 4:00 to 5:00 PM as dose 1, single for covid-19 immunisation with no adverse events. Prior vaccinations within 4 weeks were reported as none. On 20Apr2021, around 7 or 8 in the evening, the patient experienced very itchy on her arm at the place she got the vaccine shot and had a hard piece of skin, when she touches it, it was not the normal skin like on her other arm, it was itchy, it was like a hard skin. It was reported that, the conditions still itchy and hard, but not like yesterday. The reporter reported that, she said her mother shot was 20Apr2021 in the morning at 8:00. Around 7 or 8 in the evening she said her mother complained of being very itchy. The caller said do not touch was, but her mother scratched it a little then did not touch it. She said yesterday it was very itchy. The caller said she gave her mother 2 Tylenol in the day, 2 Tylenol at night, but her mother was still itchy and hard, but not like yesterday. The caller says she is concerned, her mother wants to know if she should ask if it was important, her mother was afraid of the side effects. The caller said the side effect was worse yesterday, today it was not very itchy, her mother complains about the skin she has, today it was a little bit better. The treatment medication included paracetamol (TYLENOL) in the day and at night. The outcome of the events was reported as not recovered.  No follow-up attempts are needed. No further information is expected.
flu-like symptoms; Blurry vision; Difficulty focusing; Sweating; body aches; Headaches; fever of 104; Fatigue; Chills; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu-like symptoms), VISION BLURRED (Blurry vision), DISTURBANCE IN ATTENTION (Difficulty focusing), HYPERHIDROSIS (Sweating) and PAIN (body aches) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A and 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, 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 experienced INFLUENZA LIKE ILLNESS (flu-like symptoms), VISION BLURRED (Blurry vision), DISTURBANCE IN ATTENTION (Difficulty focusing), HYPERHIDROSIS (Sweating), PAIN (body aches), HEADACHE (Headaches), PYREXIA (fever of 104), FATIGUE (Fatigue) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, INFLUENZA LIKE ILLNESS (flu-like symptoms), VISION BLURRED (Blurry vision), DISTURBANCE IN ATTENTION (Difficulty focusing), HYPERHIDROSIS (Sweating), PAIN (body aches), HEADACHE (Headaches), PYREXIA (fever of 104), FATIGUE (Fatigue) and CHILLS (Chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 104 (High) fever of 104 degree Fahrenheit.         Concomitant product use was not provided by the reporter.  Action taken with mRNA-1273 in response to the event was not applicable.   Reporter did not allow further contact
2-3 cm welt that extended up thigh about 5 minutes after injection of HIBERIX & PREVNAR - has received PREVNAR before with no problems. Cold compresses & 6.25 mg BENADRYL.
No additional adverse effects; The patient was administered expired VAQTA; This spontaneous report was received from an office manager, concerning a 22-years-old male patient. The patient's medical history, concurrent conditions, concomitant medications, and drug allergies or reactions were not reported.   On 23-JUL-2020, the patient was vaccinated with an expired vaccine of hepatitis a vaccine, inactivated (VAQTA) vial formulation, via intramuscular as prophylaxis; lot number S018419 with an expiration date on 12-JUL-2020 (expired product administrated) (strength, dose, and anatomical location were not provided). No adverse effects reported, nor product quality complain involved.
10/26 - patient was feverish 10/27 - patient woke up with 3 inch diameter puffy red welts on each arm at injection site, otherwise feels fine (fever gone, denies shortness of breath or swelling in face/neck) pharmacist at other location instructs her to take Benadryl
pt recv vax 15NOV96 & 9MAR97 pt devel over 100 pox;the pt had been exposed to varicella two wk before developed varicella;
Hours after vaccine face and trunk became red/flushed. Next day became ataxic. Redness resolved.
Narrative:  Patient was scheduled for shingrix vaccine. RN preparing the vaccine did not reconstitue the vaccine. She administered diluent only. The patient was notified and advised to reschedule in 4 wks.
severe localized react in rt upper arm (deltoid area);i.e. erythema, swelling, inc temp, involving most of upper arm;meds Chortrimeton, Keflex;
After the patient was given the vaccine it was discovered that the patient was 17. There were no reported side effects after 15 minute observation.
Client was vaccinated with Moderna vaccine for Covid in mid March and again in mid April, 2021.  Client not sure of exact dates.  Symptoms started on 9/26: nasal congestion, fatigue, fever, loss of taste and smell, dizziness.  Reported as a case of breakthrough Covid illness in previously vaccinated person.
Patient received Flumist for the first time. Began feeling ill, weak and lightheaded then had syncopal episode in a friend's car. Taken to acute care clinic and found to be tachycardic; developed hives/urticaria w/o dyspnea. Administered IV methylprednisolone, diphenhydramine, and ranitidine with complete resolution of symptoms.
Initial report received from a healthcare professional on 21 October 2014. A female patient, whose medical history and concomitant medications were not reported, had received a dose of FLUZONE QIV Adult Pre-Filled Syringe) (Batch number UI172AA and expiry date not reported) route and site of vaccination was not reported, on an unspecified date. On an unspecified date after vaccination the patient had experienced Leg Weakness (Both Legs). Corrective treatment was not reported and Laboratory data were reported as none. At the time of this report the outcome of the adverse events was unknown. List of documents held by sender: none. Follow-up information received from a health care professional on 20-JAN-2015. An 8-years-old patient had received 0.5 ml intramuscular dose of FLUZONE QIV on 17 October 2014 at 3:00 PM. On 18 October 2014, i.e. one day after vaccination the patient had the event leg weakness (both legs). The patient had food allergy in the past. At the time of this report the patient was recovered. The patient required ER visit.
Fevers as high as 105.1F , severe chills, headaches, body aches, nausea, severe fatigue
This spontaneous report as received from a registered nurse refers to a patient of unknown. The patient was vaccinated with PNEUMOVAX 23 (dose and route were unknown, Lot # reported as H013581, expiration date 03-MAR-2014). The reporter requested a Lot # check. No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patient experienced redness around injection site, rash around injection site, and "red streak" around injection site. The patient sought medical attention by an office visit. No treatment information was reported. The reporter did not have detailed individual patient information but she said 6 patients redness and rash around injection site and a couple of patients experienced fever as well (MARRS Case # 1210USA013157 and MARRS Case # 1211USA001592 respectively, same reporter link) and one patient experienced "red streak" around injection site. The outcome of rash around injection site, redness around injection site and "red streak" around injection site is unknown. The relatedness for redness around injection site, rash around injection site and "red streak" around injection site was not reported for PNEUMOVAX 23. Additional information has been requested.
I started having pain in the injection site that radiated to my shoulder and neck on the right side. I received a muscle relaxer and have gone to the chiropractor.  If I don't use the arm the pain is under control. If I do any activity then I have sever pain.
pt. recvd. 3rd dose of Hep B vax 10mcg. instead of 40mcg.
Vaccination + 3 hrs - Headache, Fatigue Vaccination + 8 hrs - Headache, Severe Fatigue (took over the counter Ibuprofen) Vaccination + 14 hrs - Severe Chills, Headache, Muscle Ache  (took over the counter Tylenol) Vaccination + 16 hrs - Cold sweats, Headache, Muscle Ache, Fever = 103 deg F  Vaccination + 20 hrs - Headache, Muscle Ache, fever = 101 deg F Vaccination + 24 hrs - Headache, Muscle Ache  (took over the counter Ibuprofen)
Shoulder where shot was administered had restricted movement; unable to push arm in certain directions without extreme pain. My wife observed that the left shoulder stuck out compared to the right when I lay down. In retrospect, I believe the shoulder was partially dislocated. After approximately 7 weeks, I felt a pop when getting out of bed and pain was reduced and mobility improved. Now (10 weeks after shot), shoulder is back to 90% function. While shoulder was suffering, I tried ice, a sling, and ibuprofen -- ice for about 2 weeks, sling for a day, ibuprofen off and on during the 7 weeks.
Severe swelling at injection site. Hard, red, raised area covering upper arm 4 inches x 5 inches.
arm sore at the injection site; vaccination site pain; redness about the size of a quarter; A spontaneous report was received from a Health care professional concerning a 78 year-old female patient who received Moderna's COVID-19 vaccine(mRNA-1273) and experienced events of vaccination site erythema, vaccination site swelling, and vaccination site pain.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 10-Jan-2021, prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 (batch unknown) in the left arm for prophylaxis of COVID-19 infection.   On 10-Jan-2021, the patient experienced injection site redness about the size of a quarter.  On 07-Feb-2021, prior to the onset of the events, the patient received the second of two planned doses of mRNA-1273 (Batch no:010M20A) in the left arm for prophylaxis of COVID-19 infection.  On 07-Feb-2021, the patient experienced sore arm at the injection site, slight swelling, and discomfort upon moving his arm away from the body. No Treatment information was provided.  Action taken with mRNA-1273 in response to the events was not applicable.  The Outcome of event was not Reported.; 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.
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. Medical assistant reported that, on an unknown date, multiple unspecified patients received a doses of ROTATEQ oral route of administration (dose, lot number and expiration were not reported) that were improperly stored. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Right arm swelled up two days after vaccine, painful down to her elbow, pain in right breast and shoulder blade. Lump underneath right arm.
Sunday, December 19th started a sore throat in the evening. More coughing and exhaustion. Had a tele visit with provider on Tuesday and was tested for flu and COVID. Both came back negative. Father tested positive later that evening. Provider was contacted and they were told to assume she is COVID positive as father has tested positive and other family members are showing symptoms. It seems her seizure threshold has been lowered since symptoms started. She was taken to the ER on Thursday, December 23rd. Is not up for doing daily activities such as opening her own gifts on Christmas morning. Was diagnosed with arthralgia and is having difficulty sleeping and staying asleep at night.
No adverse event; Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and NO ADVERSE EVENT (No adverse event) in a 69-year-old female patient who received mRNA-1273 (Spikevax) (batch no. O70H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 07-Jul-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 07-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Expired vaccine used).    Patient age was reported as 69 years 4 months. No concomitant and treatment medication were reported.
weakness to her left leg; unable to walk; left leg is reportedly without strength; This is a spontaneous report. A contactable Consumer reported that a 71-year-old female patient received (solution for injection), dose 1 via an unspecified route of administration on 06Apr2021 as SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. On an unspecified date, the patient experienced weakness to her left leg, unable to walk, left leg is reportedly without strength. Callers wife reportedly with weakness to her left leg. Her left leg is reportedly without strength and she is unable to walk on it following her vaccination on April 6th. The action taken in response to the event was not applicable. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Dose 2: pruritus after doses 2 and 5; mild facial angioedema; chest and neck urticaria; This literature-non-study case was reported in a literature article and describes the occurrence of ANGIOEDEMA (mild facial angioedema) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.   LITERATURE REFERENCE:  Administration of a Second Dose of the Moderna COVID-19.    Concurrent medical conditions included Allergic rhinitis.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jan-2021, the patient experienced ANGIOEDEMA (mild facial angioedema) (seriousness criterion medically significant). 05-Jan-2021, the patient experienced URTICARIA (chest and neck urticaria). On an unknown date, the patient experienced PRURITUS (Dose 2: pruritus after doses 2 and 5). On 05-Jan-2021, ANGIOEDEMA (mild facial angioedema) had resolved. At the time of the report, URTICARIA (chest and neck urticaria) and PRURITUS (Dose 2: pruritus after doses 2 and 5) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   For dose #1 Medical personnel at vaccination site treated patient's urticaria with 25 mg of oral diphenhydramine.  For dose #1 ER treated patient's angioedema with 20 mg of intravenous famotidine and 125 mg of methylprednisolone. For dose #2 Allergy physician administered graduated dosing of vaccine every 15 minutes. Event of pruritic developed after dose 2 and 5 but no treatment was required. No concomitant medications were reported.  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.   This case was linked to MOD-2021-085104 (E2B Linked Report).; Sender'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. MOD-2021-085104:2nd patient
Expired vaccine used; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 65-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 08-Nov-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 and treatment medications were reported. The vaccines were stored in freezer, and one to two vials were taken out and placed in fridge each day as needed. The lot number of vaccine was 026B21A(17 Sep 2021).
Localized swelling, erythema and hot to touch.  Progressively spread down towards elbow over the next day.
Arm at injection site, started hurting around 6 PM, around 6:30 noticed redness and swelling top of the arm, then in AM of 4/14 the redness and swelling moved down the arm, and now 4/19 is at the elbow.
NO SIDE EFFECTS OCCUR. PATIENT AGE MISCALCULATION, IN REVIEW PATIENT FOUND TO RECIEVE MODERNA BOOSTER , WHILE HE IS 17 YEARS OLD . PATIENT IS NOT ELIGIBLE FOR MODERNA VACCINE DUE TO AGE RISTRICTION  AND ALSO NOT ELIGIBLE FOR BOOSTER AS PER AGE RESTRICTION . UPON FOLLOW UP WITH PATIENT MOTHER , SHE MENTIONTIONED THAT HE DIDNOT GET ANY SIDE EFFECTS AND HE WENT TO SCHOOL AS REGULAR
Left side of face below eye and goes to the Botox. Of my lips has a numbing feeling.
PASSED OUT A FEW MINUTES AFTER RECEIVING 2ND DOSE OF MODERNA COVID VACCINE; HOWEVER, RECOVERED A FEW MINUTES AFTER.
significant swelling on right side of neck - from gland up to ear.  Have not yet seeked trt.
Vaccinated on 10.1.2014 Left arm. Approximately 2-3 days later felt pain in arm tingling to hand. Noticed after massage therapy and has not subsided. Used Ice and warm pack with no relief. Had appointment with Chiropractor no relief. Called physician on 10.27.14 talked with Nurse. 11.4.14 Seen by physician and placed on prednisone. Feels better in morning but hurts toward evening. (As reported to me by patient)
This spontaneous report has been received from a nurse concerning an unknown number of unspecified patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant therapy were not reported. On or after 28-MAY-2017, the patients were administered improperly stored doses of ROTATEQ (lot# M002254, expiration date 15-NOV-2017; lot# M045545, expiration date: 15-NOV-2017) (dose was not reported) orally for prophylaxis. The vaccine (lot# M002254, expiration date 15-NOV-2017; lot# M045545, expiration date: 15-NOV-2017) were exposed to temperature excursion of 32  Fahrenheit (F) to 35 F cumulative for 165 minutes (85 minutes on 28-MAY-2017, 130minutes on 29-MAY-2017, 20 minutes on 30-MAY-2017, 20 minutes on 31-MAY-2017, and 10 minutes on 01-JUN-2017); exposed to temperature excursion of 47 F to 77 F cumulative for 205 minutes (65 minutes on 15-JUN-2017 and 140 minutes on 12-JUL-2017). The data logger was involved. There was no previous temperature excursion. No adverse effect reported. This is one of three reports received from the same reporter.; Sender's Comments: US-009507513-1708USA010275: US-009507513-1709USA000641:
WHILE IN OBSERVATION AREA AFTER VACCINATION, PATIENT EXPERIENCED MILD TO MODERATE ANXIETY SYMPTOMS( HYERVENTILATING, LIGHT HEADED, NAUSEATED). VITAL SIGNS WERE ALL STABLE, SKIN MOIST. BYSTANDER ADVISED PT REACTS LIKE THIS TO MOST THINGS. RN ON SITE CHECKED GLUCOSE(116). HR-64, SPO2-96%. 2ND HR-72, 96% ROOM AIR. PATIENT WAS GIVEN JUICE, AND CALMED DOWN NOTICEABLY AFTER CONVERSATION.
Moderna Covid-19 Vaccine EUA, Minor chills, Nausea, Vomiting once, After I vomited, it all went away except having a sore arm at injection site for 48 hours.
9 hours post-vaccine, developed rigors, fever to 102.7, myalgia, headache, and nausea. Everything but fever resolved within 18 hours.  Fevers resolved by 48 hour mark.
approx 3" diameter redness, swollen, lumpy, painful @ inj site 2-3 days post vax;