chrisvoncsefalvay/vaers-outcomes huggingface dataset:
diarrhea; no appetite; ache; exposed to Covid; patient ran a fever of 102; chills; lack of energy; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea), DECREASED APPETITE (no appetite), PAIN (ache), EXPOSURE TO SARS-COV-2 (exposed to Covid) and PYREXIA (patient ran a fever of 102) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (diarrhea), DECREASED APPETITE (no appetite), PAIN (ache), EXPOSURE TO SARS-COV-2 (exposed to Covid), PYREXIA (patient ran a fever of 102), CHILLS (chills) and FATIGUE (lack of energy). On 12-Mar-2021, PAIN (ache), PYREXIA (patient ran a fever of 102), CHILLS (chills) and FATIGUE (lack of energy) had resolved. At the time of the report, DIARRHOEA (diarrhea) and DECREASED APPETITE (no appetite) had resolved and EXPOSURE TO SARS-COV-2 (exposed to Covid) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102 (High) 102.      No Treatment information was provided.  No Concomitant medication was provided.  COVID-19 test result was not reported.   This case was linked to MOD-2021-058062 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 11-Aug-2021: Follow up received on 11-AUG-2021 and does not contain any new information.
Rhabdomyolysis; She had a high D-dimer but there were no clots; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 24-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Mar2023 as dose number unknown (booster), single (Lot number: GL0447) at the age of 24 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization. The following information was reported: RHABDOMYOLYSIS (hospitalization, medically significant) with onset 15Mar2023, outcome "unknown"; FIBRIN D DIMER INCREASED (hospitalization) with onset Mar2023, outcome "unknown", described as "She had a high D-dimer but there were no clots". The patient was hospitalized for rhabdomyolysis, fibrin d dimer increased (hospitalization duration: 4 day(s)). The patient underwent the following laboratory tests and procedures: Blood creatine phosphokinase (normal high range 100): (Mar2023) 77000; Blood test: (Mar2023) Unknown Results, notes: followed to make sure that kidney were not affected; Fibrin D dimer: (Mar2023) high. Therapeutic measures were taken as a result of rhabdomyolysis and high D-dimer.  Additional information: One of my patients actually ended up getting admitted with Rhabdomyolysis and she had actually worked out the day before the vaccine, she was a physical therapist, sports trainer, she was 24 years old, and she had worked out the day before. The next day she worked and with elderly doing physical therapy, this was 15Mar2023 and after working that day and not doing that much physically because they were older people, she went in she got a Pfizer Bivalent vaccine. The next day she actually started to feel very achy to the point that she could not walk down the stairs and she actually just put up with it. The next day was Friday and it was to the point that her urine turned tea color and she called the doctor on the Saturday, she shouldn't do too much that day and then she got admitted to the hospital (Further hospitalization details was not available over the call hence event captured as per verbatim). A normal CK (Creatinine Kinase) was about a 100-Creatinine kinase her was 77000 and she needed hydration and fortunately there was no kidney damage. The urine returned to normal, she had a high D-dimer but there were no clots.  The patient was admitted to a hospital, and she was hydrated over four days and the blood test (Further name of test was not clarified) was followed to make sure that kidney were not affected. She was hydrated.; Sender's Comments: Based on information provided, the events are inter-current conditions, thus unrelated to the suspect drug.
Rash around right eye. Redness with pseudovescicles. This seems very unlikely to be related to vaccination, but I received a call from v-safe asking me to fill out this form.
patient experienced tingling in her lips and scratchy throat at ~ 10 minutes after vaccination. Patient took diphenhydramine 25mg PO on her own at 10:50. 11:00 not feeling well, team responded, BP 157/89, RH 75, pulse Ox 100%. We remained with patient for 15 more minutes. Patient's symptoms resolved. She was escorted to her car and feeling back to normal.
This spontaneous report as received from a healthcare worker refers to unknown number of patients of unknown age and gender. Current conditions and medical history were not reported. On unknown dates, the patients were vaccinated with doses of improperly stored ROTATEQ suspension 2 (unknown dose and strength; route defaulted to oral) (incorrect product storage). Concomitant medications were not reported. No adverse effect was reported. The outcome of the events was unknown. No product quality complaint was involved. Additional information has been requested.
Improperly stored VARIVAX was administered; no adverse event; This spontaneous report was received from a nurse (also reported as office manager) and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported.  On an unknown date, the patient was vaccinated with improperly stored doses of varicella virus vaccine live (oka/merck)(VARIVAX) lot # T025947, expiration date 30-JUL-2022 (administration route, dose and frequency were not reported) for prophylaxis.   The improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) experienced multiple excursions as they were stored from -50 Celsius degrees (C) to -15C, with an average temperature of -12.8C for 40 minutes, and also with an average of -12.7C during 1 hour. There was a previous temperature excursion with an average temperature of -12.8C, for 40 minutes (reported twice). The call was because of a data logger.No additional adverse event or product quality complaint (PQC) were involved.
Patient reports that he had erythema and bruising in his right arm after the vaccination. This has occurred for approximately 2 weeks and has gone down since. He is not reporting any pain, fever or discomfort.
Pain day after injection and the day after. Exactly one week after injection, red/swelling/itchy at injection site and swollen lymphnods in armpit, mild pain when touched.
For 2 days after vaccine on 8/29/18 patient reported "normal" side effects (headache, fever). At around 11pm on 8/31/18 pt started to get "sensation waves" down both arms and felt a burning pain.  She felt coldness and numbness down her legs. Pt also reported a "vibration feeling in head". When asked to elaborate she said it wasn't like a headache but felt like her "brain was vibrating". These symptoms lasted for a few days and patient described the feeling, discomfort, and pain as "awful". On 9/4/18 when this was reported to the pharmacy patient said she feels much better and feels like she "just crawled out of a cave".  She has some burning in her hands but the burning increases with activity. She has minor numbness in legs which also increases with activity. Patient has scheduled a follow-up appointment with her Primary Care Physician for 9/5/18.
On 10/06, patient developed rash on legs/feet, annular rash (with urticarial component described by mom, improved by time seen in office).  Seen 10/09 with couple dozen annular macular, erythematous lesions.  Some coalesing up to 3 cm each, no target lesions, or urticaria on 10/09.  Lesions were only on lower extremities, and beginning to fade on 10/09.
Patient became blue, eyes rolled back and baby tensed up. Mom gave mouth to mouth; baby became pink again and brought to ER. Admitted for work-up; all negative; Started on Phenobarb for seizure disorder 6/27/03-6/30/03. Presented to ER again with seizure; one seizure observed in ED. ER and hospital records state fever.
Broke with hives on my back, legs , lower back and arms lasted for more than a week so I saw my family physician and they prescribed Methylprednisolone to stop the hives
This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 62-year-old female patient who received SHINGRIX (batch number NX952, expiry date 6th March 2020) for prophylaxis. On 10th April 2018 10:45, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was not recovered/not resolved. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on the left arm. In 2018, the patient experienced soreness in her arm for 3 weeks and it had not completely resolved. On 25th June 2016, the patient went to the pharmacy to get her 2nd dose of SHINGRIX. The 2nd dose was not administered as the pharmacist was looking for more information about this situation before giving it. The patient did want to get the 2nd dose.
Entire body started to ache-got worse-Pain level 8/9, bursts of pain in both heels at level 10- in bed for two days. Headache-3 days. Nausea (mild). Shivering while in bed - 2 days. Upper right arm extremely sore, red, hot - still, on 11/6 (also swelling) finally, completely gone after 2 weeks. (The 1st SHINGREX caused only soreness, redness and warmth for appox. 31/2 days) (Also bad fatigue). Never had any prior adverse reactions to any vaccines: pneumonia, flu, and what seemed like "hundreds" - only short-term and mild soreness.
positive at home pregnancy test 2/4/21 (same date as vaccine given).  However, light bleeding/spotting started that night/next day but thought still normal.  Heavier bleeding started 2/6/21 (Saturday) and continued through the weekend. Made appointment at hospital lab for Monday 2/8 to check HcG levels in blood.  See below for details, but Dr. suggested repeat blood work on 2/10 as Hcg levels showed positive pregnancy, but very low.  2/10 Hcg levels slightly lower, which confirmed early miscarriage occurring.
Recieved two Janssen COVID19 vaccines 1st shot Janssen 09/02/2021 LOT: 1816027 2nd shot Janssen 09/17/2021 LOT: 043A21A
Patient had constant shivering , skin felt clammy, increase in heart rate  and blood pressure  after 15 minutes of receiving the 1st dose Moderna vaccine. EMS was called and evaluated the  patient and informed patient she had anxiety. No reaction to the vaccine  and recommend to go home and rest or if symptoms worsen to go the ER. Patient left the site and went home.
The injection site became itchy on Thursday (7/12/12) evening & started to swell on Friday & Saturday. The swelling started to go down on Sunday but the itchiness remained through Monday.
Seen in our ER 2 days after vaccination with Pneumovax (not sure where she received it) c/o pain, edema and erythema at vaccine injection site (left arm). Erythema and edema initially extended from shoulder to elbow. When patient presented to ER, erythema and edema still persisted lower half of upper arm. Afebrile in ER (temp of 98.1). Rated her pain as 3/10 and described pain as burning. MD diagnosis states Acute Cellulitis after Pneumovax. Treatmentin ER included Zithromax 500 mg PO and Decadron 8 mg PO. Also given prescriptions for Zithromax Z-Pak & Decadron.
The day the vaccination was administered the patient developed pain in his left arm near the site of the injection. Pain has not radiated to any other site. It has remained within 3 inches of initial shot location. The pain lasted approximately 2 weeks, then subsided to a constant dull ache. When the patient exercises and lift weights the pain intensifies again. It has now been 2  months since his vaccination, so he should not be experiencing pain any longer.   The patient has not taken any medication to treat the pain
Pt received his first SHINGRIX vaccine at 15:25 on 4/13/18 to his right deltoid. On 4/16/18 at 09:30 a 1.5cm x 1cm red area with a 0.5cm x 0.5cm clear blister was noted on his right deltoid. Below the blister was an area 5cm x 3cm of blotchy redness which was slightly warm to touch. Pt complained his arm was sore. On 4/17 there was a circular area with tiny blisters to the center with no open areas. On 4/19 the blisters were improving with no intervention. On 4/23 and 4/24/18 the area was scabbed and decreasing in size. No pain or open areas.
facial redness for 1 noc, then resolved; 14DEC93 f/u also had facial itch & was wheezy, resolved;
Soreness In Injection Arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Soreness In Injection Arm) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. O12M2OA) for COVID-19 vaccination.     No Medical History information was reported.    On 31-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 VACCINATION SITE PAIN (Soreness In Injection Arm). At the time of the report, VACCINATION SITE PAIN (Soreness In Injection Arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Chest pain and shortness of breath. This started on the evening of the second dose. Onset a few hours after dose given 8/21/2021. Never hypoxic. Remained outpatient. Saw PCP on 8/24/2021.  Referral to cardiologist scheduled for 8/27/2021. Symptoms improving. Advised to refrain from strenuous exercise for 12 weeks. Diagnosed with post-vaccine myocarditis.
Chills; Muscle pain; Diarrhea; Administration date 27Oct2021 at 11:00, dose number=3; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old non-pregnant female patient received the third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0196) via an unspecified route of administration in the right arm on 27Oct2021 at 11:00 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Medical history included breast cancer diagnosed in 2019. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included anastrozole (MANUFACTURER UNKNOWN) and vitamin d nos (MANUFACTURER UNKNOWN) and calcium (MANUFACTURER UNKNOWN); all taken for unknown indication from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3247) via an unspecified route of administration in the right arm on 24Feb2021 (at the age of 50-years-old) and also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3247) via an unspecified route of administration in the right arm on 17Mar2021 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. The patient previously received influenza vaccine (MANUFACTURER UNKNOWN) on 28Sep2021 (at the age of 50-years-old) for immunization. On 27Oct2021 at 11:00, the patient had "administration date 27Oct2021 at 11:00, dose number=3". On 28Oct2021 at 14:00, the patient experienced chills, muscle pain and diarrhea. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of events chills, muscle pain and diarrhea and included treatment with ibuprofen (ADVIL). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events chills, muscle pain and diarrhea was resolved on an unknown date in Oct2021. The clinical outcome of the event "administration date 27Oct2021 at 11:00, dose number=3" was unknown at the time of this report.
Swollen right arm at and all around the injection site. Red hive looking swelling from shoulder to elbow. At this time is is still spreading past the point it was on 2/11/21. Went to ER to have it looked at. They said it was an infection and prescribed Cephalexin 500 mg. I pointed out the I had the vaccine less than two weeks before and the swelling is all around that site. It is even redder at the exact site. As of today it is no better and is spreading. We looked up side effects and the pictures are exactly like my arm.
approximately 2 inch long x 1.5 inch swelling under left armpit identified  2 days after vaccine administration.  no redness or pain.  Complained of general pain in  the arm and "deep inside" his left shoulder.  Has good range of motion.
Pfizer BioNTech COVID 19 vaccine EUA-  fever, headache, fatigue.  Fever lasted less than 23 hours. no  medications still have slight HA
This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 53 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 19Dec2021 (Lot number: 331308A) at the age of 53 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EW0151), administration date: 13Apr2021, when the patient was 52 years old, for Covid-19 immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: ER8735, Location of injection: Arm Left), administration date: 04May2021, when the patient was 52 years old, for Covid-19 immunization.  The following information was reported: IMMUNISATION (non-serious) with onset 19Dec2021, outcome "unknown", described as "dose_number=3"; PAIN IN EXTREMITY (non-serious) with onset Dec2021, outcome "not recovered", described as "pain in my left arm/recurring pain in my right". The event "pain in my left arm/recurring pain in my right" was evaluated at the physician office visit. Therapeutic measures were not taken as a result of pain in extremity.  Additional information: The patient had constant pain in my left arm, recurring pain in my right. It's painful to brush my hair, painful to sleep at night. In my biceps, very painful. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient had not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
itching at the injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site itching in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included COVID-19 VACCINE (COVID 19 BOOSTER) for prophylaxis.   On 9th May 2022, the patient received the 1st dose of Shingrix (intramuscular) .5 ml and the 2nd dose of COVID 19 BOOSTER. In May 2022, several days after receiving Shingrix, the patient experienced injection site itching. On an unknown date, the outcome of the injection site itching was recovered/resolved.   It was unknown if the reporter considered the injection site itching to be related to Shingrix.     Linked case(s) involving the same patient: Additional Information: Receipt Date: 24-May-2022 Reporter's Comments: The patient got her first Shingrix vaccine in the left deltoid and 2nd COVID booster (on unknown arm) at the same time. A few days after her first vaccine, she had itching at the injection site that lasted a few days. In May 2022, outcome for injection site itching was recovered.  The reporter consented to follow up. Additional Supportive Information: For tolerance of 2nd dose of Shingrix vaccine, refer linked case reported by same reporter. Sender's Comments: same reporter.
Patient fully vaccinated. Patient is COVID + on 11/19/2021. 81y.o. female who came to the ER with nausea/emesis with fatigue and weakness. CXR was negative for acute processes. She has been on room air. D dimer 609.  Admission Dx:  palpitations, AKI, pneumonia due to COVID.  She improved with conservative management with steroids, lovenox. No need for any Decadron or remdesivir at present. Started the patient on Lovenox 40 mg once a day for DVT prophylaxis. She was discharged home once cleared by all services.
Throat tightness, dry mouth, numbness in L arm- evaluated by EMS-cleared
This spontaneous report was received from a nurse, referring to a 13-year-old female. Information about her historical conditions, drug reactions or allergies and concomitant medications were not provided. On 28-FEB-2019, the patient was vaccinated in a private doctor's office/hospital with second dose of GARDASIL 9 by intramuscular route, in the right deltoid, for prophylaxis, lot number N026814 and expiration date 15-JUL-2020, but a nurse was pulled out the needle out, therefore, some of liquid shot out. The reporter mentioned that she felt that the patient did not get the full dose, she was removing the needle from the injection site and after the complete removal, the fluid shot out of the arm (underdose), subsequently she cleaned the side of injection and applied a band aid. However, it was confirmed with the nurse that none of the vaccine got on the patient or the nurse's skin. It was reported that the patient was anxious during the vaccination and that the deltoid was very tense. Also, it was reported that during the same day, the patient was vaccinated with first dose of VAQTA by intramuscular route, in the left arm, for prophylaxis, lot number R013515 and expiration date 30-MAY-2019 and fourth dose of INFECTOVAC FLU, by intramuscular route, in the left arm, for prophylaxis and lot number 4DY9K (expiration date were not reported). No adverse effects were reported. There was no Digital Data Logger involved.
She received her vaccine, didn't really have any feelings.  She went to get her glasses and when they checked her eyes they could not give her a prescription as she was bleeding behind her right eye.  She is now going for injections in her eye, which was very painful and does not know if it is helping or not yet.  She will be going back to see her doctor shortly.
Rash on arm; red; bumpy; itchy; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (Rash on arm), VACCINATION SITE PRURITUS (itchy), VACCINATION SITE ERYTHEMA (red) and VACCINATION SITE MASS (bumpy) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2020, the patient experienced VACCINATION SITE PRURITUS (itchy). On 19-Feb-2021, the patient experienced VACCINATION SITE RASH (Rash on arm), VACCINATION SITE ERYTHEMA (red) and VACCINATION SITE MASS (bumpy). At the time of the report, VACCINATION SITE RASH (Rash on arm), VACCINATION SITE PRURITUS (itchy), VACCINATION SITE ERYTHEMA (red) and VACCINATION SITE MASS (bumpy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
30JAN97 t100, cough & chest congestion;4FEB97 pt given med x 21 days;