chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Itchiness around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itchiness around the injection site) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     Concurrent medical conditions included Obesity and Blood pressure high.   On 12-Mar-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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced VACCINATION SITE PRURITUS (Itchiness around the injection site). At the time of the report, VACCINATION SITE PRURITUS (Itchiness around the injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient's weight is given as 316 (unit unknown). No treatment medications were provided. No concomitant medications were reported. The patient stated one knot may have been from the first shot of vaccine she never noticed. She said she have been rubbing it, moving around, alleviate. At time of reporting pain has reduced but the knot still persist in pea size.   This case was linked to MOD-2021-079388 (Patient Link).
hard to lift head; Body hurts/body aches; feels exhausted/fatigue; chills; This spontaneous case was reported by a consumer and describes the occurrence of HEAD DISCOMFORT (hard to lift head), PAIN (Body hurts/body aches), FATIGUE (feels exhausted/fatigue) and CHILLS (chills) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced HEAD DISCOMFORT (hard to lift head), PAIN (Body hurts/body aches), FATIGUE (feels exhausted/fatigue) and CHILLS (chills). At the time of the report, HEAD DISCOMFORT (hard to lift head), PAIN (Body hurts/body aches), FATIGUE (feels exhausted/fatigue) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant information were not provided by the reporter. Treatment information were not provided by the reporter.
This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19), INFLUENZA LIKE ILLNESS (Flu like symptoms) and ARTHRALGIA (SORE JOINTS MOSTLY ELBOWS AND KNEES/JOINT PAIN FROM WRIST TO OPPOSITE ELBOW) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Co-suspect product included non-company product IBRUTINIB (IMBRUVICA) for Chronic lymphoid leukemia. There was no reported medical history. Concurrent medical conditions included Chronic lymphoid leukemia. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and IBRUTINIB (IMBRUVICA) (Oral) at an unspecified dose. In December 2021, the patient experienced COVID-19 (COVID-19). On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms) and ARTHRALGIA (SORE JOINTS MOSTLY ELBOWS  AND KNEES/JOINT PAIN FROM WRIST TO OPPOSITE ELBOW). At the time of the report, COVID-19 (COVID-19) and INFLUENZA LIKE ILLNESS (Flu like symptoms) had resolved and ARTHRALGIA (SORE JOINTS MOSTLY ELBOWS  AND KNEES/JOINT PAIN FROM WRIST TO OPPOSITE ELBOW) had not resolved. Concomitant medication information was not provided by the reporter. The reporter's causality for the events was not reported with respect to IMBRUVICA (IBRUTINIB). Treatment information was not provided by the reporter. Company Comment: This spontaneous case concerns a 60-year-old, male patient with current condition of Chronic lymphocytic leukemia and treated with Ibrutinib who experienced the unexpected, non-serious adverse event of special interest of COVID-19 which occurred an unknown interval after receiving an unknown dose number of mRNA-1273. The clinical course, diagnostic evaluation including SARS-CoV-2 test and treatment information were not provided in the report. At the time of report, COVID-19 has resolved. Underlying chronic lymphocytic leukemia and treatment with Ibrutinib are associated with abnormalities in immune function and increased risk for infections. The benefit-risk relationship of mRNA-1273 is not affected by this report. Sender's Comments: This spontaneous case concerns a 60-year-old, male patient with current condition of Chronic lymphocytic leukaemia and treated with Ibrutinib who experienced the unexpected, non-serious adverse event of special interest of COVID-19 which occurred an unknown interval after receiving an unknown dose number of mRNA-1273. The clinical course, diagnostic evaluation including SARS-CoV-2 test and treatment information were not provided in the report. At the time of report, COVID-19 has resolved. Underlying chronic lymphocytic leukemia and treatment with Ibrutinib are associated with abnormalities in immune function and increased risk for infections. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Lymph node abnormalities; This is a spontaneous report from a non-contactable Consumer. This consumer reported for a patient that a patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: Unknown) via an unspecified route of administration on an unspecified date as 1st dose, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It is reported that reporter came across the below news today, on 04Feb2021, which was about suspected side effect after vaccination with Comirnaty product. Lymph node abnormalities (on an unspecified date) after COVID vaccine. Outcome of event was unknown.  No follow up attempts are possible. Information about Lot/batch number cannot be obtained.
Fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Fever). At the time of the report, PYREXIA (Fever) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported. No treatment medication was reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-083106, US-MODERNATX, INC.-MOD-2021-083652 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-083106:Crossed linked US-MODERNATX, INC.-MOD-2021-083652:Son's case
BECAME FLUSHY RED, DIZZY. HAD HER REMAIN SITTING. SAID SHE FELT FINE SO ASSOCIATE WALKED HER OUT TO HER CAR. THEN SHE SAID HER LIP STARTED TO TINGLE, DROVE CLOSE TO HER SONS HOUSE WHO TOOK HER TO THE HOSPITAL
NECK PAIN (WITH RADIATION); SHORTNESS OF BREATH; BLURRED VISION; CONFUSION; BULGE IN NECK ON LEFT SIDE/NECK SWELLING; WHOLE LEFT SIDE OF BODY IS  SWOLLEN; SEVERE INFLAMMATION; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight was 240 pounds, and height was not reported. The patient's concurrent conditions included ankylosing spondylitis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978 expiry: UNKNOWN) dose was not reported, administered on 03-APR-2021 12:05 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, Laboratory data included: Electrocardiogram (NR: not provided) Electrocardiogram (units unspecified). On 03-APR-2021, the subject experienced neck pain (with radiation). On 03-APR-2021, the subject experienced shortness of breath. On 03-APR-2021, the subject experienced blurred vision. On 03-APR-2021, the subject experienced confusion. On 03-APR-2021, the subject experienced bulge in neck on left side/neck swelling. On 03-APR-2021, the subject experienced whole left side of body is swollen. On 03-APR-2021, the subject experienced severe inflammation. On 08-APR-2021, Laboratory data included: Blood test (NR: not provided) blood work. Treatment medications included: diazepam, and prednisone. On 13-APR-2021, Laboratory data included: Blood test (NR: not provided) blood work. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from neck pain (with radiation), shortness of breath, blurred vision, confusion, bulge in neck on left side/neck swelling, whole left side of body is swollen, and severe inflammation. This report was non-serious.; Sender's Comments: V0:20210417102-Ccovid-19 vaccine ad26.cov2.s-Neck pain. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY, UNDERLYING DISEASE
Pt recvd Engerix-B in late 1990 & 1991 30NOV90; 3JAN91 & 29MAY91 which resulted in no conversion according to last antibody test 5NOV91;
Swelling at injection site; Redness at injection site; Soreness at injection site; Plus some pain in both hip joints, left is getting better now but the right is getting worse. Right one; Stiffness at injection site; This spontaneous case was reported by a health care professional and describes the occurrence of INJECTION SITE SWELLING (Swelling at injection site), INJECTION SITE ERYTHEMA (Redness at injection site), INJECTION SITE PAIN (Soreness at injection site), ARTHRALGIA (Plus some pain in both hip joints, left is getting better now but the right is getting worse. Right one) and MUSCULOSKELETAL STIFFNESS (Stiffness at injection site) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No adverse event reported). Concomitant products included LISINOPRIL, ESOMEPRAZOLE SODIUM (NEXIUM [ESOMEPRAZOLE SODIUM]), CALCIUM and VITAMINS NOS for an unknown indication.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced INJECTION SITE SWELLING (Swelling at injection site), INJECTION SITE ERYTHEMA (Redness at injection site), INJECTION SITE PAIN (Soreness at injection site), ARTHRALGIA (Plus some pain in both hip joints, left is getting better now but the right is getting worse. Right one) and MUSCULOSKELETAL STIFFNESS (Stiffness at injection site). At the time of the report, INJECTION SITE SWELLING (Swelling at injection site), INJECTION SITE ERYTHEMA (Redness at injection site), INJECTION SITE PAIN (Soreness at injection site) and MUSCULOSKELETAL STIFFNESS (Stiffness at injection site) was resolving and ARTHRALGIA (Plus some pain in both hip joints, left is getting better now but the right is getting worse. Right one) outcome was unknown.        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 treatment information provided
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Seizure" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Cipro, reaction(s): "Allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative; Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Red rash on left forearm and back of left hand.  Lasted 48 hours.  High, uncontrolled blood glucose, unable to correct using insulin pump and additional insulin delivery. (Held over 300 mg/dl) Lasted 30 hours.  Within 48 hours all symptoms alleviated.
Hives all over immediately that lasted 96 hours. Used Benadryl every 4-6 hours. Stayed at pharmacy at least 30-60  minutes after injection. Had epipen ready if needed.
Pain at the application site on the day 06/10/21. Left axillary lymph adenomegaly on 10/07/21. Left axillary pain on 10/07/21 without improvement with analgesic. Fatigue on 10/07/21 improved with analgesic.
Beginning on May 13, I?ve experienced heavy headedness, dizziness, and some nausea on 5/13, 5/14, and 5/15
Red, swollen, sore/tender, itchy on injection site; Red, swollen, sore/tender, itchy on injection site; Red, swollen, sore/tender, itchy on injection site; Red, swollen, sore/tender, itchy on injection site; Swollen, sore spot in armpit; Swollen, sore spot in armpit; This is a spontaneous report received from a contactable consumer (patient). A 43-year-old female non-pregnant patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; Lot Number: EL1283), via an unspecified route of administration on left arm on 26Jan2021 08:00 as single dose for COVID-19 Immunization. Medical history included ongoing high blood pressure, ongoing prediabetes and allergic to sulfa. Concomitant medications included ethinylestradiol/norgestimate (TRI-SPRINTEC 28), losartan, metformin, vitamin D3 daily, ascorbic acid (VITAMIN C) daily and calcium, magnesium. The patient previously took lisinopril and experienced allergy. The patient historical vaccine included first dose of BNT162B2 (Lot number: EK5730) on 06Jan2021 (at 43-year-old) on right arm for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 27Jan2021, the patient experienced red, swollen, sore/tender, itchy on injection site and swollen, sore spot in armpit. The Patient did not receive any treatment for the events. The events were assessed as non-serious by the reporter. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since vaccination. The outcome of the events was reported as recovering.  Follow-up attempts completed. No further information expected.
Received Immunizations and Rotavirus #1 on 4-17-07. Patient vomited all night and appeared as if she had stomach pain. Had normal BM on 4-18-07 was seen and examined in office on 4-18-07 and advised to go to ER if symptoms persisted or if patient became inconsolable. CFNP felt symptoms were and reaction to Rotavirus vaccine.
Starting on December 2, a day after receiving the Moderna booster shot in my left arm, I noticed pain and swelling in the muscle around my left armpit. The area was puffy and tender to the touch. I continued to experience pain and swelling on December 3 and 4. Since I had never had this happen after a vaccination before, on December 4, I held a telehealth visit with RN who works at my doctor's office. She looked at the area on video, and asked me questions about my symptoms. She believed that the pain and swelling were muscular (rather than a swollen lymph node; at her direction, I attempted to feel any "hard ball" in the area, but did not feel anything like that). She advised that the swelling and pain would probably resolve within a few days. The pain and swelling reduced on December 5-6, and were gone on December 7.
Patient got 1st dose of Shingrix on 8/11/2020. According to patient about 1 week later on 8/18/2020, patient felt like there was a bruise forming on her outer left thigh. When patient looked at the site, there was nothing visible on her thigh but skin in the area was sensitive to touch, painful and felt like a "brush-burn".  About another week later on 8/29/2020, patient finally noticed a rash cluster on the same area she was feeling pain and upon further inspection, the rash seems to have spread to the crease in the groin area. The area is still sensitive to touch and has not resolved.
This is a spontaneous report from a contactable consumer (patient). A 81-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection Batch/Lot number: EP7534, Expiration Date was not reported), via an unspecified route of administration, administered in left arm on 18 Mar 2021 (at the age of 81-year-old) as 1st dose, single dose for COVID-19 immunization. The patient medical history included chest pain, high cholesterol, congestion in her throat and lungs. It occurred prior to Christmas 2020. She had issues from COVID-19 and stated that she feels weaker because she used to walk like 4 miles a day and now, she was not walking due to the pandemic. Concomitant medications included atorvastatin (LIPITOR [ATORVASTATIN], taken for high cholesterol; acetylsalicylic acid (ASPIRIN 81). Patient did a cardiac test, and they came back negative. Heart was fine. It still has not resolved though. Patient reported that she had the first dose last week and had a couple of things that she needed to report. She usually has a rapid heartbeat and has always been able to feel her heart beating and been able to hear heart beating. Caller said that she had her heart tested because of her having a rapid heart rate previously. Caller said that since the dose, she could not feel any sensations around her heart and even if she turns over to push up on her arm, she could usually feel her heartbeat and now she could not. She also could not hear it anymore. She said that it is kind of strange, unusual for her. Caller said that she could feel her heartbeat when she was watching TV. Caller said that she could not feel any sensations around her heart now on 18Mar2021. She said that the next night, 19Mar2021, she felt a buzz from her feet up her left size up to her neck. It was like a shock buzz, but it did not last. Last night, 21Mar2021, she had from her waist to her chest a big jolt to her system. It was just the one jolt. She tried to call her doctor to report this, and they directed her to call Pfizer. She said that she feels fine otherwise. She said that she has gained weight during the pandemic. Caller said that her not being able to feel the sensation in her heart started the evening of her receiving the vaccine 18Mar2021. Her toes do feel like there is a different sensation in them, but they are not really numb, but feel different. That started on the second night 19Mar2021 and this ongoing. It does not feel bad, just different. Second dose was scheduled for 08Apr2021. She may not get it if her symptoms are not resolved. The outcome of the event cannot feel any sensations around her heart and toes do feel like there was a different sensation in them was not resolved, outcome was resolved for events felt a buzz on 19Mar2021, outcome was resolved for event had from her waist to her chest, a big jolt to her system on 21Mar2021.
Bad my currently suffering some pains after getting a booster short of Pfizer.; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non-HCP), Program ID:  The reporter is the patient.  An adult male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete, unknown manufacturer.), for COVID-19 Immunization. The following information was reported: PAIN (non-serious), outcome "unknown", described as "Bad my currently suffering some pains after getting a booster short of Pfizer.". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Medical assistant calling to report a temperature excursion that occurred 8/14/2020 which involved the following products: GARDASIL9, PEDVAXHIB, RECOMBIVAX, ROTATEQ. Per caller, "it would be possible that at least 100 patients have received vaccines; This spontaneous report was received from a medical assistant, concerning a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies or concomitant medications were not reported.  On 13-AUG-2020, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) 0.5 ml orally as prophylaxis (lot # 1660974 with expiration date 20-APR-2021) (strength and frequency were not reported).  The improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) experienced a temperature excursion of 35.4 Fahrenheit degrees (°F) for the time frame of 20 minutes without previous temperature excursions. It was confirmed that a digital data logger was involved.  This is one of several cases from the same reporter.; Sender's Comments:  US-009507513-2009USA006106:
pt recvd vax & had intense pain & burning from shoulder to elbow w/numbness & tingling from elbow to fingerstipe;devel rash next morning on non-injected arm;numbeness & tingling in non-injected arm
Child with (age 26 mos) should have been given .25ml dose but received a .5 ml dose. Age of patient at time of event: 2 years 3 months 4 days. Type of Event: Wrong age.
Shot administered IM, Left arm. She sat for 10 minutes then walked and shopped in store. At checkout she fainted - came back to Pharmacy sat for 40 mins. Had shaking tremors (very slight) white as a ghost, very weak, but did not faint again. Gave her water then she left to get something to eat with her mother and brothers.
JANSSEN VACCINE TAKEN AFTER TWO DOSES OF PFIZER; OFF LABEL USE; This spontaneous report received from a health care professional concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient was previously treated with bnt 162 for prophylactic vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, expiry: 24-JUL-2021) dose was not reported, administered on 12-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-JUL-2021, the subject experienced janssen vaccine taken after two doses of pfizer. On 12-JUL-2021, the subject experienced off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the janssen vaccine taken after two doses of pfizer and off label use was not reported. This report was non-serious.
fever elevated to 103, pain, swelling lt arm, n/v;gen aching/malaise, h/a;
Gave FLUVIRIN vaccine to patient. Patient bled and a tender lump formed where administered. Held patient for 10 minutes, no further symptoms. Told patient to ice area and call with any questions or worsens.